DEVICE: EL-ANA PROFILES: ANA/7 (00854473003088)
Device Identifier (DI) Information
EL-ANA PROFILES: ANA/7
102-005
In Commercial Distribution
102-005
THERA-TEST LABORATORIES, INC
102-005
In Commercial Distribution
102-005
THERA-TEST LABORATORIES, INC
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 60 TESTS OF 7 INDIVIDUAL ANITGENS
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 54850 | Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple antibodies associated with systemic lupus erythematosus (SLE) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 55132 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 55129 | SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 55160 | Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 55145 | Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-Smith (anti-Sm) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 54902 | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to double stranded DNA (anti-dsDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
| 55183 | Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to single stranded DNA (anti-ssDNA) in a clinical specimen, using an enzyme immunoassay (EIA) method.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| No Product Codes | |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K051066 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c05e691c-a54d-4af1-8188-1a21491b5a95
July 07, 2023
3
August 15, 2016
July 07, 2023
3
August 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined