Filled Vial, Clean-up, 330uL 800-00191

GUDID 10888234100621

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, reagent
Primary Device ID10888234100621
NIH Device Record Key4c74e21d-6431-4a68-baeb-9dd2488e2bd1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilled Vial, Clean-up, 330uL
Version Model Number800-00191
Catalog Number800-00191
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
GS110888234100621 [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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