FDA UDI
In Commercial Distribution
🇺🇸 United States
AtheNA Multi-Lyte® T. pallidum IgG Plus Test System
DI: 00845533000116
·
Model: A76101G
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AtheNA Multi-Lyte® T. pallidum IgG Plus Test System
- Primary DI
- 00845533000116
- Version / Model
- A76101G
- Catalog Number
- A76101G
- 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
- 4edfcf6d-b965-46a2-b4fd-e5b331662256
Device Description
The ZEUS AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is a multiplex flow immunoassay intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to T. pallidum specific antigen, in conjunction with non treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. This test is for In Vitro diagnostic use only. This test is not intended for screening blood or plasma donors.
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 |
|---|---|---|---|---|
| 51805 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000116 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius