FDA.reportPublic FDA data

Thermo Scientific

Primary DI
00673693418034
Brand
Thermo Scientific
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
AP-9003-125
Device description
Citrate Buffer For Heat-Induced Epitope Retrieval
Published
2018-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693418034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693418034006736934180346736934180340673693418034

GMDN Terms#

Term, Definition table
TermDefinition
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen, using an enzyme immunohistochemistry method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume125Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336182765VENTANA pan-TRK (EPR17341) AssayVentana Medical Systems, Inc.NJT2026-03-16
00847627042637Pan TRK [RM423]BIOCARE MEDICAL LLCNJT2026-02-19
07613336231395PAX-8 (SP348) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-02-16
00847627042279CK7BIOCARE MEDICAL LLCNJT2026-01-29
00847627042033DesminBIOCARE MEDICAL LLCNJT2026-01-13
00847627042835CD19BIOCARE MEDICAL LLCNJT2026-01-13
00847627041937Myeloperoxidase (P)BIOCARE MEDICAL LLCNJT2026-01-06
00847627042514VimentinBIOCARE MEDICAL LLCNJT2026-01-06
00615233011435Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233011442Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233013996Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014009Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014474Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014481Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014559Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014566Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00847627042019CD43BIOCARE MEDICAL LLCNJT2025-12-16
00847627042118Cytokeratin 18 (CK18)BIOCARE MEDICAL LLCNJT2025-12-16
00847627042491CD79aBIOCARE MEDICAL LLCNJT2025-12-16
00847627042576Cytokeratin [AE1] LMWBIOCARE MEDICAL LLCNJT2025-12-16
00847627042897CD103 (RM)BIOCARE MEDICAL LLCNJT2025-12-16
04015630971176Bluing ReagentVentana Medical Systems, Inc.NJT2025-12-15
04015630971299Amplification KitVentana Medical Systems, Inc.NJT2025-12-15
04015630972128CONFIRM anti-ALK1 (ALK01) Primary AntibodyVentana Medical Systems, Inc.NJT2025-12-15
07613336158357VENTANA Red ISH DIG Detection KitVentana Medical Systems, Inc.NJT2025-12-15
07613336158418VENTANA Silver ISH DNP Detection KitVentana Medical Systems, Inc.NJT2025-12-15
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNJT2025-11-25
00847627042132CD7BIOCARE MEDICAL LLCNJT2025-11-25
00847627042965Pan Melanoma Cocktail-2BIOCARE MEDICAL LLCNJT2025-11-17
00847627039095Desmoglein 3BIOCARE MEDICAL LLCNJT2025-09-19