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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
00810047420781N/AScientific Device Laboratory, Inc.JTS2023-01-31