FDA.reportPublic FDA data

Giemsa Staining Kit

Primary DI
04015630971404
Brand
Giemsa Staining Kit
Company
Ventana Medical Systems, Inc.
Model
05279224001
Catalog number
05279224001
Published
2025-12-15
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
HYFGIEMSA STAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYFGiemsa StainHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630971404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630971404040156309714044015630971404

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
07613336239025VENTANA MTAP (SP530) Rabbit Monoclonal Antibody10574518001105745180012026-06-08
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

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Primary DI, Brand, Company table
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00630414619255Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323596Atellica HEMA SMS W-G StainSiemens Healthcare Diagnostics Inc.HYF2026-02-06
00630414323602Atellica HEMA SMS W-G BufferSiemens Healthcare Diagnostics Inc.HYF2026-02-06
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00848838027086REMELREMEL, INC.HYF2022-12-23
00613647023631FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
00613647023648FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07
20613647023635FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.HYF2022-12-07