FDA.reportPublic FDA data

BenchMark Special Stains AFB Staining Kit

Primary DI
07613336157510
Brand
BenchMark Special Stains AFB Staining Kit
Company
Ventana Medical Systems, Inc.
Model
08432503001
Catalog number
08432503001
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ICLCARBOL FUCHSIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICLCarbol FuchsinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336157510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336157510076133361575107613336157510

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184042521
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
07613336236987VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody10496410001104964100012026-05-18
07613336239063Congo Red Stain Core Kit10585021001105850210012026-04-10
07613336239544Gram Stain Core Kit10608358001106083580012026-04-10
04015630984787SSR Solution06890059001068900590012021-02-03
07613336226568VENTANA® U6 DIG Probe10062746001100627460012026-03-26
07613336240281ASSY RGT DSPNR CARD BMK PREP KIT 30110637412001106374120012026-03-20
07613336240298ASSY RGT DSPNR CARD BMK PREP KIT 30210637439001106374390012026-03-20
07613336240304ASSY RGT DSPNR CARD BMK PREP KIT 30310637447001106374470012026-03-20
07613336240311ASSY RGT DSPNR CARD BMK PREP KIT 30410637455001106374550012026-03-20
07613336240328ASSY RGT DSPNR CARD BMK PREP KIT 30510637463001106374630012026-03-20
07613336240335ASSY RGT DSPNR CARD BMK PREP KIT 30610637471001106374710012026-03-20
07613336240342ASSY RGT DSPNR CARD BMK PREP KIT 30710637480001106374800012026-03-20
07613336240359ASSY RGT DSPNR CARD BMK PREP KIT 30810637498001106374980012026-03-20
07613336240366ASSY RGT DSPNR CARD BMK PREP KIT 30910637501001106375010012026-03-20
07613336240373ASSY RGT DSPNR CARD BMK PREP KIT 31010637536001106375360012026-03-20
07613336240380ASSY RGT DSPNR CARD BMK PREP KIT 31110637544001106375440012026-03-20
07613336240397ASSY RGT DSPNR CARD BMK PREP KIT 31210637552001106375520012026-03-20
07613336240403ASSY RGT DSPNR CARD BMK PREP KIT 31310637579001106375790012026-03-20
07613336240410ASSY RGT DSPNR CARD BMK PREP KIT 31410637587001106375870012026-03-20
07613336240427ASSY RGT DSPNR CARD BMK PREP KIT 31510637595001106375950012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693089265EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICL2024-08-07
00848838065767REMELREMEL, INC.ICL2022-12-23
00848838065958REMELREMEL, INC.ICL2022-12-23
00816085022086Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-10
00816085023458Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023595Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020822Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020853Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023441Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023588Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
04015630971732AFB III Staining KitVentana Medical Systems, Inc.ICL2021-02-08
SO359852042008Rowley Biochemical Kinyoun's Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO490852042008Rowley Biochemical Carbol FuchsinTRANSENE COMPANY, INC.ICL2019-09-16
30382902125113BD BBL™ TB Carbolfuchsin ZNBECTON, DICKINSON AND COMPANYICL2018-05-25
30382902125182BD BBL™ TB Carbolfuchsin KFBECTON, DICKINSON AND COMPANYICL2018-05-25