FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380158971
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CHB-AGS-SK
Catalog number
CHB-AGS-SK
Device description
Stain Kit for Use with Single Slide Automated Gram Stainer
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
JTSSTAINS, MICROBIOLOGIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380158971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538015897110885380158971

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014105Teco Diagnostics Hema StainTECO DIAGNOSTICSJTS2026-07-31
00673693089180EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693089197EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693201957EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-06
00673693089258EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
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
00810047420743N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420750N/AScientific Device Laboratory, Inc.JTS2023-01-31