Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Monkey Esophagus distal 4 Well Slide (each) FDA UDI
- Model / Reference
- 0604-ESD FDA UDI
- Description
- Monkey Esophagus distal 4 Well Slide (each) FDA UDI
Identifiers
- Catalog Number
- 0604-ESD FDA UDI
- Primary DI / UDI-DI
- 00813545026707 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
No
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 by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Scimedx Corp.
Sources (1)
- FDA UDI 83aade2c-ec25-41df-a423-6f02ce806e7e 36 fields · synced May 31, 2026