EL-ANA Profiles: anti-Centromere 104-111

GUDID 00854473003170

ANTI-CENTROMERE ANTIBODY ELISA TEST KIT, 96 TESTS

THERA-TEST LABORATORIES, INC

Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00854473003170
NIH Device Record Key4b16dec8-9ba9-41d9-a7d1-b33b911eeab3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEL-ANA Profiles: anti-Centromere
Version Model Number104-111
Catalog Number104-111
Company DUNS194336954
Company NameTHERA-TEST 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

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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100854473003170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-15

Devices Manufactured by THERA-TEST LABORATORIES, INC

00854473003347 - EL-ANA PROFILES: ANA/82023-07-14 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TEST OF 8 INDIVIDUAL ANITGENS
00854473003354 - EL-ANA PROFILES: ANA/62023-07-14 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS OF 6 INDIVIDUAL ANTIGENS
00854473003323 - EL-Anti-SARS-CoV-2 IgM2023-07-07 ANTI-SARS-CoV-2 IgM ANTIBODY ELISA TEST KIT, 96 TESTS
00854473003330 - EL-Anti-SARS-CoV-2 IgG2023-07-07 ANTI-SARS-CoV-2 IgG ANTIBODY ELISA TEST KIT, 96 TESTS
00854473003316 - EL-Anti-SARS-CoV-22020-05-12 ANTI-SARS-COV-2 ANTIBODY ELISA TEST KIT, 192 TESTS
00854473003309 - EL-ANA PROFILES: ANA/42018-07-20 ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 24 TESTS OF 4 INDIVIDUAL ANTIGENS
00854473003002 - EL-ANA PROFILES: EL-ANAscr2018-03-29 ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 96 TESTS
00854473003019 - EL-anti-CCP/22018-03-29 ANTI-CCP/2 ANTIBODY ELISA TEST KIT, 192 TESTS

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