ENVOY 500 AST REAGENT KIT

GUDID 03701700800330

VITALSCIENTIFIC

Total aspartate aminotransferase (AST) IVD, kit, spectrophotometry
Primary Device ID03701700800330
NIH Device Record Key97f0e5b7-24d2-490d-a894-69d289a62936
Commercial Distribution StatusIn Commercial Distribution
Brand NameENVOY 500 AST REAGENT KIT
Version Model Number55255
Company DUNS267732378
Company NameVITALSCIENTIFIC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
GS103701700800330 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

On-Brand Devices [ENVOY 500 AST REAGENT KIT]

0370170080033055255
0370170080004055250

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