Trinity Biotech 2325300

GUDID 05391516743433

Captia™ Rubella IgG

CLARK LABORATORIES, INC.

Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516743433
NIH Device Record Key068f3933-9694-4d12-b1b4-58e28c45f5a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number2325300
Catalog Number2325300
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
GS105391516743433 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFXEnzyme Linked Immunoabsorbent Assay, Rubella

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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