Bio-Rad Platelia 72938

GUDID 05391516746564

EBV-EA-D IgG

CLARK LABORATORIES, INC.

Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516746564
NIH Device Record Key06a3c67b-c505-4a9f-ba5f-fc8efc9fd70d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Rad Platelia
Version Model Number72938
Catalog Number72938
Company DUNS623214079
Company NameCLARK LABORATORIES, INC.
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

Customer Support Contacts

Phone1-800-325-3424
Emailcustomerservice@trinityusa.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516746564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSEEpstein-Barr Virus, Other

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-22
Device Publish Date2019-11-14

On-Brand Devices [Bio-Rad Platelia]

05391516746571EB-NA-1 IgG
05391516746557EBV-VCA IgG
05391516746540EBV-VCA IgM
05391516746564EBV-EA-D IgG

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