FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA ENA Profile-6 Test System
DI: 00845533000550
·
Model: 2Z2801G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
6
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA ENA Profile-6 Test System
- Primary DI
- 00845533000550
- Version / Model
- 2Z2801G
- Catalog Number
- 2Z2801G
- Company Name
- ZEUS SCIENTIFIC, INC.
- Labeler DUNS
- 080953946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9bde5f84-4d6e-4693-8d2a-14954942cb51
Device Description
The ZEUS ELISA ENA Profile-6 Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Jo-1, Sm, Sm/RNP, SSA(Ro), SSB(La), and Scl-70 in human sera. When performed according to these instructions, the results of this autoantibody profile may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55126 | Scleroderma-70 antibody (anti-Scl-70) 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 scleroderma-70 (anti-Scl-70) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Active |
| 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. | No | Active |
| 55005 | Jo-1 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-Jo-1 antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000550 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius