Trinity Biotech 2325500

GUDID 05391516743495

Captia™ Herpes Simplex Virus 2 (HSV 2) IgG

CLARK LABORATORIES, INC.

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516743495
NIH Device Record Keyc9a9fb2e-4303-4f1c-b8e6-ce5d830db731
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number2325500
Catalog Number2325500
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
GS105391516743495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQOAntisera, Cf, Herpesvirus Hominis 1,2

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-06
Device Publish Date2016-09-23

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05391516745109CAPTIA™ Syphilis TA EIA
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05391516745031CAPTIA™ CMV TA EIA
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