FDA.reportPublic FDA data

Gram Stain Core Kit

Primary DI
07613336239544
Brand
Gram Stain Core Kit
Company
Ventana Medical Systems, Inc.
Model
10608358001
Catalog number
10608358001
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HYIIODINE, GRAMS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYIIodine, GramsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336239544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336239544076133362395447613336239544

GMDN Terms#

Term, Definition table
TermDefinition
Cytokeratin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen.

Regulatory Flags#

DUNS number
184042521
Device count
1
Premarket exempt
true
Kit
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
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
07613336240434ASSY RGT DSPNR CARD BMK PREP KIT 31610637609001106376090012026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693090025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYI2024-09-05
00673693090179EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYI2024-09-05
00848838065590REMELREMEL, INC.HYI2022-12-23
00848838065606REMELREMEL, INC.HYI2022-12-23
00848838065675REMELREMEL, INC.HYI2022-12-23
00848838066085REMELREMEL, INC.HYI2022-12-23
00848838066092REMELREMEL, INC.HYI2022-12-23
00848838066108REMELREMEL, INC.HYI2022-12-23
00848838066115REMELREMEL, INC.HYI2022-12-23
04015630984787SSR SolutionVentana Medical Systems, Inc.HYI2021-02-03
00840733102905Para-Pak C&S in BiobagsMERIDIAN BIOSCIENCE, INC.HYI2020-10-06