Trinity Biotech 2325601

GUDID 05391516747066

Captia™ Varicella-Zoster Virus (VZV) IgG

CLARK LABORATORIES, INC.

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516747066
NIH Device Record Key1ba615b9-35ba-41a3-9ee3-9c743de75915
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number2325601
Catalog Number2325601
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
GS105391516747066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQXAntiserum, Cf, Varicella-Zoster

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-07
Device Publish Date2016-09-23

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05391516747141Captia™ ds/DNA
05391516747110Captia™ Mumps IgG
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05391516747059Captia™ Herpes Simplex Virus 2 (HSV 2) IgM
05391516747042Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
05391516747035Captia™ Herpes Simplex Virus 1 (HSV 1) IgM
05391516747028Captia™ Herpes Simplex Virus 1 (HSV1) IgG
05391516747011Captia™ Rubella IgM
05391516747004Captia™ Rubella IgG
05391516746991Captia™ Cytomegalovirus (CMV) IgM
05391516746984Captia™ Cytomegalovirus (CMV) IgG
05391516746977Captia™ Toxoplasma gondii IgM
05391516746960Captia™ Toxoplasma gondii IgG
05391516746939Captia™ HSV 2 Type Specific IgG
05391516746922Captia™ HSV 1 Type Specific IgG
05391516746496Captia™ Herpes Group IgG
05391516746489Captia™ Herpes Simplex Virus (HSV) Combined IgM
05391516745147Captia™ Malaria EIA
05391516745130CAPTIA™ Malaria EIA
05391516745123CAPTIA™ Malaria EIA
05391516745109CAPTIA™ Syphilis TA EIA
05391516745093CAPTIA™ Syphilis TA EIA
05391516745048CAPTIA™ NMT Syphilis IgM
05391516745031CAPTIA™ CMV TA EIA
05391516745024CAPTIA™ CMV TA EIA
05391516744836CAPTIA™ Syphilis (T. Pallidum)-G
05391516744829CAPTIA™Syphilis (T. Pallidum)-G
05391516744065Bartels ELISA Legionella Urinary Antigen
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05391516743914Captia™ANA Screen
05391516743891Captia™ PR-3
05391516743877Captia™ MPO
05391516743860Captia™ ENA Combined Screen
05391516743839Captia™ Mitochondria
05391516743822Captia™ ENA Profile
05391516743808Captia™ Thyroglobulin
05391516743792Captia™ Jo-1
05391516743785Captia™ Scl-70
05391516743778Captia™ Sm/RNP
05391516743761Captia™ Smith (Sm)
05391516743754Captia™ SSB (La)

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