FDA UDI
In Commercial Distribution
🇺🇸 United States
ELISA L. pneumophila IgG/IgM/IgA Smart Kit Test System
DI: 00845533000796
·
Model: SM3Z15051
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELISA L. pneumophila IgG/IgM/IgA Smart Kit Test System
- Primary DI
- 00845533000796
- Version / Model
- SM3Z15051
- Catalog Number
- SM3Z15051
- 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
- 3
- Public Version Date
- 2021-08-09
- Public Version Status
- Update
- Public Device Record Key
- 0d11ce90-8e58-4dd0-93cf-4f5b6b9a557d
Device Description
The ZEUS ELISA Legionella pneumophila IgG/IgM/IgA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of total antibody (IgG/IgM/IgA) to Legionella pneumophila serogroups 1-6 in human sera. 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 |
|---|---|---|---|---|
| 51076 | Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM 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 immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to one or multiple serogroups of Legionella pneumophila in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Legionella pneumophila, the bacteria associated with Legionnaires' disease. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000796 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius