FDA.reportPublic FDA data

Cholesterol Gen.2

Primary DI
04015630924967
Brand
Cholesterol Gen.2
Company
Roche Diagnostics GmbH
Model
05168538190
Catalog number
05168538190
Published
2021-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHHEnzymatic Esterase--Oxidase, CholesterolClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031824000COBAS INTEGRA CHOLESTEROL GEN. 2Roche Diagnostics Corp.2003-07-09CHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630924967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630924967040156309249674015630924967

GMDN Terms#

Term, Definition table
TermDefinition
Total cholesterol lipid IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total cholesterol lipid in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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