Trinity Biotech 2322671

GUDID 05391516745031

CAPTIA™ CMV TA EIA

CLARK LABORATORIES, INC.

Cytomegalovirus (CMV) total antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516745031
NIH Device Record Key99417cef-5f20-4aab-ad14-9f3d5a7ee1f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number2322671
Catalog Number2322671
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
GS105391516745031 [Primary]

FDA Product Code

LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-06
Device Publish Date2016-09-22

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