Immucor Precise TypeTM Human Erythrocyte Antigen M 800-20202-96

GUDID 10888234102618

BIOARRAY SOLUTIONS LTD

Multiple blood group genotyping IVD, kit, microarray
Primary Device ID10888234102618
NIH Device Record Key92df75a0-2723-492a-a113-3684dacddb5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmucor Precise TypeTM Human Erythrocyte Antigen M
Version Model Number800-20202-96
Catalog Number800-20202-96
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 Kittrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store carrier box in 2 to 8 degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store reagent box in -80 to -20 degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234102618 [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

On-Brand Devices [Immucor Precise TypeTM Human Erythrocyte Antigen M]

10888234102618800-20202-96
10888234100065800-20202-08

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