FDA.reportPublic FDA data

Lipase colorimetric assay

Primary DI
04015630926985
Brand
Lipase colorimetric assay
Company
Roche Diagnostics GmbH
Model
05401704190
Catalog number
05401704190
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
CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHILipase-Esterase, Enzymatic, Photometric, LipaseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972250000ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTSRoche Diagnostic Systems, Inc.1997-08-12JFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630926985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630926985040156309269854015630926985

GMDN Terms#

Term, Definition table
TermDefinition
Lipase IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of lipase 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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