EL-ANA PROFILES: EL-ANAscr 100-002

GUDID 00854473003002

ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 96 TESTS

THERA-TEST LABORATORIES, INC

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00854473003002
NIH Device Record Key6cde720f-97c4-4645-a035-e9fba953a710
Commercial Distribution StatusIn Commercial Distribution
Brand NameEL-ANA PROFILES: EL-ANAscr
Version Model Number100-002
Catalog Number100-002
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
GS100854473003002 [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

On-Brand Devices [EL-ANA PROFILES: EL-ANAscr]

00854473003057ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 192 TESTS
00854473003002ANTI-NUCLEAR ANTIBODY SCREEN ELISA TEST KIT, 96 TESTS

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.