FDA.reportPublic FDA data

SSR Solution

Primary DI
04015630984787
Brand
SSR Solution
Company
Ventana Medical Systems, Inc.
Model
06890059001
Catalog number
06890059001
Published
2021-02-03
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
HYIIODINE, GRAMS
JTSStains, microbiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYIIodine, GramsHematology1
JTSStains, MicrobiologicHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630984787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630984787040156309847874015630984787

GMDN Terms#

Term, Definition table
TermDefinition
Anaplastic lymphoma kinase 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 anaplastic lymphoma kinase, also known as ALK protein, CD246 or p80, in a clinical specimen.

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
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
07613336239544Gram Stain Core KitVentana Medical Systems, Inc.HYI2026-04-10
00673693089180EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693089197EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693201957EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693089258EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693090025EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYI2024-09-05
00673693090179EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYI2024-09-05
00673693169011EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693236461EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693168984EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-09
00673693168991EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
00673693169080EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
00810047422068N/AScientific Device Laboratory, Inc.JTS2024-07-11
30382902125250BD BBL™ Gram Crystal VioletBECTON, DICKINSON AND COMPANYJTS2023-09-19
00810047421986N/AScientific Device Laboratory, Inc.JTS2023-08-31
00810047421863N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421887N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421894N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421900N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047421948N/AScientific Device Laboratory, Inc.JTS2023-06-08
00810047420378N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420385N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420392N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420453N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420613N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420620N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420705N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420712N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420729N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420736N/AScientific Device Laboratory, Inc.JTS2023-01-31