FDA.reportPublic FDA data

Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation

Primary DI
04015630928934
Brand
Aspartate Aminotransferase acc to IFCC without pyridoxal phosphate activation
Company
Roche Diagnostics GmbH
Model
5850819190
Catalog number
5850819190
Published
2016-09-20
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
CITNadh oxidation/nad reduction, ast/sgot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951595000ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTESRoche Diagnostic Systems, Inc.1995-09-08CGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630928934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630928934040156309289344015630928934

GMDN Terms#

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

Storage And Handling#

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

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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00380740155735ARCHITECTABBOTT IRELANDCIT2022-06-14
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