Identity
- Trade Name
- IFA AMA Test System FDA UDI
- Generic Name
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative and semi-quantitative detection of Mitochondrial Antibodies (MA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- FA3001 FDA UDI
- Description
- The ZEUS IFA Anti-Mitochondrial Antibody (AMA) Test System is designed for the qualitative and semi-quantitative detection of Mitochondrial Antibodies (MA) by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- FA3001 FDA UDI
- Primary DI / UDI-DI
- 00845533001410 FDA UDI
- GMDN Term
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay 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: Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay
IFA AMA Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 4339bebd-5608-4d71-89e1-cb075d61f8a6 35 fields · synced May 30, 2026