FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885380173172
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
CH2465605
Catalog number
CH2465605
Device description
TDM/Beta-Hydroxybutyrate Bi-Level Controls
Published
2019-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DIFDrug mixture control materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIFDrug Mixture Control MaterialsClinical Toxicology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885380173172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088538017317210885380173172

GMDN Terms#

Term, Definition table
TermDefinition
Beta-hydroxybutyrate IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of beta-hydroxybutyrate (3-hydroxybutyric acid) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690286000742MEDTOX®MEDTOX DIAGNOSTICS, INC.DIF2026-03-31
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00810042684355DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-19
00810042684362CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2025-03-17
00810042683822DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2025-02-20
00810042684331DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684348DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-12-09
00810042684324CliawaivedBIOCHEMICAL DIAGNOSTICS INCDIF2024-11-21
00810042684263DETECTABUSEBIOCHEMICAL DIAGNOSTICS INCDIF2024-10-31
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