Lipase colorimetric assay 3029590322

GUDID 04015630917570

Roche Diagnostics GmbH

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Primary Device ID04015630917570
NIH Device Record Key974831b9-8b02-4998-9d15-562ac2080c3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipase colorimetric assay
Version Model Number3029590322
Catalog Number3029590322
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630917570 [Primary]

FDA Product Code

CHILIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-26
Device Publish Date2021-01-18

On-Brand Devices [Lipase colorimetric assay]

0761333612139908057982190
040156309175703029590322
040156309269855401704190

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