Identity
- Trade Name
- AtheNA Multi-Lyte® RF IgM Plus Test System FDA UDI
- Generic Name
- Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- A91101M FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- A91101M FDA UDI
- Primary DI / UDI-DI
- 00845533000086 FDA UDI
- GMDN Term
- Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex
AtheNA Multi-Lyte® RF IgM Plus Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI 5bd7d5d7-2319-46d3-9f6a-d869f5d40305 35 fields · synced May 30, 2026