FDA UDI
In Commercial Distribution
🇺🇸 United States
AtheNA Multi-Lyte® RF IgM Plus Test System
DI: 00845533000086
·
Model: A91101M
·
ZEUS SCIENTIFIC, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AtheNA Multi-Lyte® RF IgM Plus Test System
- Primary DI
- 00845533000086
- Version / Model
- A91101M
- Catalog Number
- A91101M
- 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
- 5bd7d5d7-2319-46d3-9f6a-d869f5d40305
Device Description
The ZEUS AtheNA Multi-Lyte® Rheumatoid Factor (RF) IgM Plus Test System is intended for the qualitative and/or quantitative detection of RF IgM class antibody. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. This test is for In Vitro diagnostic use only.
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 |
|---|---|---|---|---|
| 54846 | Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with rheumatoid arthritis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at rheumatoid factor (RF) and/or cyclic citrulline peptide. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00845533000086 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius