Trinity Biotech 2338170

GUDID 05391516743822

Captia™ ENA Profile

CLARK LABORATORIES, INC.

Multiple extractable nuclear antigen auto-antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
Primary Device ID05391516743822
NIH Device Record Key6e02af96-42b5-4624-afcb-0889eabf94b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number2338170
Catalog Number2338170
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
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com
Phone1-800-325-3424
EmailCustomerservice@trinityusa.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516743822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLLExtractable Antinuclear Antibody, Antigen And Control

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 Date2016-09-22

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05391516747240ACE CONTROL-E
05391516747233ACE CONTROL-N
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05391516747189Captia™ Borrelia burgdorferi IgG/IgM
05391516747172Captia™ ENA Combined Screen
05391516747165Captia™ Histone
05391516747158Captia™ Rheumatoid Factor IgM
05391516747141Captia™ ds/DNA
05391516747110Captia™ Mumps IgG
05391516747066Captia™ Varicella-Zoster Virus (VZV) IgG
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
05391516743952Captia™ Chlamydia IgG
05391516743938Macra® Lp(a)
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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