Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- AEmA (anti-endomysial) Monkey Esophagus distal 96 Test Kit FDA UDI
- Model / Reference
- 6001-96-ESD-R FDA UDI
- Description
- AEmA (anti-endomysial) Monkey Esophagus distal 96 Test Kit FDA UDI
Identifiers
- Catalog Number
- 6001-96-ESD-R FDA UDI
- Primary DI / UDI-DI
- 00813545027100 FDA UDI
- 510(k) Number
- K993034 FDA UDI
- FDA Product Code
- MVM FDA UDI
- GMDN Term
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- 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
No
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: Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
MeDiCa is a precision-assay, automated test kit for detecting anti-endomysial antibodies (anti-EMA) in clinical specimens. Using fluorescent immunoassay technology, MeDiCa accurately measures the levels of these antibodies, providing reliable and reproducible results.
Similar devices
Also classified as Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay.
- Histofluor® Primate Esophagus Autoantibody Fluorescent Test System — IMMUNO CONCEPTS INC
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IFA: Oesophagus (Monkey) IgA EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- IFA: Oesophagus (Monkey) IgA EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- Histofluor® Primate Esophagus Autoantibody Fluorescent Test System — IMMUNO CONCEPTS INC
- IFA: Oesophagus (Monkey) IgA EUROPattern — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
Cleared under the same submission
K993034 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scimedx Corp.
Sources (1)
- FDA UDI 2dabb7a6-e071-4ce2-bf63-4298b3ea32db 36 fields · synced Jun 23, 2026