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37 matching records for Reagent.

NDC#

Sysmex Reagents America, Incorporated

Isopropyl Alcohol

DailyMed#

Array

Sysmex Reagents America, Incorporated

2020-04-20

GMDN Terms#

Assay development analyte-specific reagent IVD

4,626 GUDID devices

An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological...

Donor blood photochemical treatment kit

16 GUDID devices

A collection of sterile devices and reagent solution intended to be used in vitro with an ultraviolet (UV) blood illuminator for photochemical treatment of donor blood (including whole blood, plasma, and/or platelet concentrates) to inactivate blood transfu...

Indole/Kovac's microbial reagent IVD

12 GUDID devices

A substance or reactant, sometimes referred to as indole reagent or Kovac's reagent, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid ...

Group A2 Rh (D) negative reagent red blood cell IVD, antigen

4 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A2 Rh(D) negative. These reagent cells are positive for blood group antigen A [ABO001] but negative ...

Kell negative reagent red blood cell IVD, antigen

2 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as Kell negative. These reagent cells are negative for blood group antigen K [KEL001].

Di^a positive reagent red blood cell IVD, antigen

1 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as Di^a positive. These reagent cells are positive for the Diego blood group antigen Di^a [DI001].

Group A1 Rh (D) negative reagent red blood cell IVD, antigen

1 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A1 Rh(D) negative. These reagent cells are positive for blood group antigen A1 [ABO004] and negative...

Group A2 Rh (D) positive reagent red blood cell IVD, antigen

1 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group A2 Rh(D) positive. These reagent cells are positive for blood group antigen A [ABO001] and Rh(D) [RH...

Group B Rh(D) negative reagent red blood cell IVD, antigen

1 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group B Rh(D) negative. These reagent cells are positive for blood group antigen B [ABO002], and negative ...

Group O Rh (D) negative reagent red blood cell IVD, antigen

1 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as blood group O Rh (D) negative. These reagent cells are negative for blood group antigens A [ABO001], B [ABO002] ...

DNA-based tissue typing IVD, reagent

232 GUDID devices

A reagent which is intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic marker...

Chromogenic substrate reagent IVD

80 GUDID devices

A reagent or solution that gives off colour in a biochemical reaction, intended to be used in combination with other IVDs in the testing of a clinical specimen, typically using an enzyme immunoassay method.

Reagent grade alcohol solution IVD

59 GUDID devices

A reagent grade alcohol solution (e.g., methanol, ethanol, isopropanol) intended to be used as a dehydrant in the processing of biological tissues or clinical specimens.

Histology tissue processing reagent kit IVD

48 GUDID devices

A collection of reagents intended to be used for tissue processing in a histology laboratory to prepare biological tissues or clinical tissue specimens for embedding, or related procedures, by successively removing water and alcohol. It may consist of a fix...

Antibody screening reagent red blood cell IVD, kit, agglutination

24 GUDID devices

A collection of two or three specifically characterized reagent red blood cells that are supplied together as a set and intended to be used when screening a clinical specimen to detect antibodies to red blood cell antigens, using an agglutination method.

Instrument/analyser specimen/reagent container carrier IVD

16 GUDID devices

A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen ...

Nucleic acid technique (NAT) kit IVD

15 GUDID devices

A collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions ...

Catalase production microbial reagent IVD

8 GUDID devices

A substance or reactant, sometimes referred to as hydrogen peroxide reagent, intended to be used in microbial testing to detect the enzyme catalase produced by a microorganism isolated from a clinical specimen by culture.

Voges-Proskauer (VP) microbial reagent IVD

8 GUDID devices

One or multiple substances or reactants, referred to as VP (Voges-Proskauer) reagent, intended to be used in microbial testing to determine the ability of a microorganism, isolated from a clinical specimen by culture, to convert pyruvate to acetoin.

Nucleic acid amplification mastermix reagent IVD

7 GUDID devices

A reagent intended to be used in combination with sequence-specific primers, probes and/or controls to facilitate the amplification of a target nucleic acid sequence [i.e., deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)} in a clinical specimen, using...

Beta-lactamase production microbial reagent IVD

5 GUDID devices

A substance or reactant, sometimes referred to as nitrocefin reagent, intended to be used in microbial testing to detect the enzyme beta-lactamase, produced by a microorganism isolated from a clinical specimen by culture.

Cystatin C IVD, reagent

4 GUDID devices

A reagent which is intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cystatin C protein in a clinical specimen.

Immunoassay reagent vehicle tray IVD, reusable

3 GUDID devices

A removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.

Immunoglobulin-sensitized reagent red blood cell IVD, control

3 GUDID devices

A sample of reagent red blood cells sensitized to or coated with antibodies [e.g., immunoglobulin G (IgG) or immunoglobulin M (IgM)] intended to be used to verify the performance of an assay (e.g., Coombs control) for evaluation of a clinical specimen.

Bile solubility microbial reagent IVD

2 GUDID devices

A substance or reactant, sometimes referred to as sodium deoxycholate reagent, intended to be used in microbial testing for the presumptive identification of Streptococcus pneumoniae by determining the solubility of suspect colonies isolated from a clinical...

Complement coated reagent red blood cell IVD, control

2 GUDID devices

A sample of specifically characterized reagent red blood cells intended to be used when testing a clinical specimen due to their sensitization or cell coating with complement associated proteins, to verify the performance of an assay.