Identity
- Trade Name
- Immco Diagnostics, Inc. FDA UDI
- Generic Name
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AMA-M2 Screen ELISA FDA UDI
- Model / Reference
- 5163S FDA UDI
- Description
- AMA-M2 Screen ELISA FDA UDI
Identifiers
- Catalog Number
- 5163S FDA UDI
- Primary DI / UDI-DI
- 00845714002526 FDA UDI
- FDA Product Code
- DBM FDA UDI
- GMDN Term
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5090 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Immco Diagnostics, Inc. by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA UDI d92ffc12-08d1-4356-b3c9-cb6a1e0ea3b5 38 fields · synced Sep 17, 2026