Glucose UV REAGENT

GUDID 00817238011148

Glucose UV REAGENT

CLINIQA CORPORATION

Glucose IVD, reagent
Primary Device ID00817238011148
NIH Device Record Key106ed6c7-5b3c-4d35-8d89-6b8e35935bbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlucose UV REAGENT
Version Model NumberR85411
Company DUNS078742335
Company NameCLINIQA CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817238011148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFRHexokinase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-04
Device Publish Date2018-08-23

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