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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

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
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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