RICHARD-ALLAN SCIENTIFIC LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18316381831638RICHARD-ALLAN SCIENTIFIC LLC1N2026-01-014481 CAMPUS DR. KALAMAZOO MI US 49008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2388721902793436K061360NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)MYA2006-06-27
2388722003387522K060462NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2)MXZ2006-04-24
2388721030003192
2388721060340467
2388721098262511
2388721133206196
2388721137530694
2388721157683702
2388721210877764
2388721214686655
2388721230956047
2388721240647072
2388721257856653
2388721299719777
2388721303659022
2388721311232822
2388721326424653
2388721339246070
2388721341253568
2388721352632314
2388721357996696
2388721363549357
2388721381946288
2388721390136998
2388721431295453
2388721452321101
2388721481812064
2388721538521555
2388721546069863
2388721564356941
2388721575376817
2388721575838676
2388721584251241
2388721608631037
2388721616664700
2388721665180590
2388721675695104
2388721678358929
2388721686806797
2388721688447042
2388721692688541
2388721707800651
2388721712029004
2388721723533962
2388721776876739
2388721778250856
2388721781675442
2388721818304341
2388721830311306
2388721835230659
2388721850016282
2388721860344223
2388721861353963
2388721893816346
2388721903005481
2388721946250943
2388721971592510
2388721984258074
2388721992334777
2388721996074759
2388722019260092
2388722026103495
2388722060301126
2388721302226974

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MYA22006-06-27
MXZ22006-04-24

GUDID#

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-29

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore, they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-28

Epredia - """The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore theymust be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use."""

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-28

Epredia - The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore theymust be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-28

Epredia - """The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore theymust be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use."""

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-28

Epredia - """The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore theymust be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use."""

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-28

Epredia - """Hematology stains are typically mixtures of several thiazin dyes in a methanol solvent. Ionic and non-ionic forces are involved in the binding of the dyes. The negatively charged phosphoric acid groups of DNA attract the purple polychromatic cationic dyes to the nuclei. The blue basophilic granules are stained by the polychromatic cationic dyes. Cationic cellular components, such as the erythrocytes and eosinophilic granules, are stained by the red and pink anionic dyes. The buffers used in the staining procedure liberate and activate dye ions allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solution and/or buffer is a critical factor. The Wright, Wright-Giemsa, Giemsa, May-Grunwald and Jenner stains all rely on a separate buffer solution to control the pH of the reaction, whereas the buffered versions are referred to as “one-step” and have the buffering component already in the staining solution. There are pros and cons to each type of hematology stain although they all contain the thiazin dyes which control the coloration of the nuclear cell components. The single solutions with buffer included generally present more precipitate and the cellular detail is not defined as well as using separate stain and buffer solutions. This kit contains three 500ml bottles of Wright Giemsa stain, pH 6.8 Buffer and a Rinse solution intended to be used as a system per the instructions for use."""

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-10-21

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

Epredia - Cassettes are designed to contain incised tissue safely and securely for tissue processing, embedding, and sectioning. The cassettes are made of an acetyl copolymer designed to be solvent resistant during the normal tissue processing protocol. Specimen security can only be provided when Cassettes are used with approved and tested lids. Use of non-approved lids may lead to lid detachment during tissue processing. All cassettes with the exception of the Thinline and Fine Pore Cassette measure (H) 42.5mm, (W) 28.5mm, (D) 6.0mm. They are available in a range of colors. Differing in pore size and shape, there are three types available: Embedding, Biopsy, and Slotted. The choice of pore size is based on tissue type, size, and processing capabilities. The Histoscreen cassette utilizes a nylon mesh filter screen in the place of the typical pore sizes to be utilized for small, friable tissue that might escape the typical pore configurations during tissue processing. The Thinline and Fine Pore Cassettes have intermediate pore sizes between the Histoscreen and the traditional cassettes offering an injection moulded version with smaller pore size. Different coloured cassettes may be used to identify patient or tissue type.

RICHARD-ALLAN SCIENTIFIC COMPANY

2024-09-24

80 records. Showing 1-40. Next