Filled Vial, Lambda Exonuclease 800-00195

GUDID 10888234100683

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, reagent
Primary Device ID10888234100683
NIH Device Record Keyc51afdea-db6e-41ce-b25e-aff146dcad93
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilled Vial, Lambda Exonuclease
Version Model Number800-00195
Catalog Number800-00195
Company DUNS949103725
Company NameBIOARRAY SOLUTIONS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234100683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEPMolecular Erythrocyte Typing Test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

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