Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Skin antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- ASA (anti-skin) Monkey Esophagus 48 Test Kit FDA UDI
- Model / Reference
- 6001-48-ES FDA UDI
- Description
- ASA (anti-skin) Monkey Esophagus 48 Test Kit FDA UDI
Identifiers
- Catalog Number
- 6001-48-ES FDA UDI
- Primary DI / UDI-DI
- 00813545027124 FDA UDI
- 510(k) Number
- K902237 FDA UDI
- FDA Product Code
- DBL FDA UDI
- GMDN Term
- Skin antibody 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: Skin antibody 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 Skin antibody IVD, kit, fluorescent immunoassay.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- ASA (Monkey Esophagus) — ZEUS SCIENTIFIC, INC.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IFA ASA Test System — ZEUS SCIENTIFIC, INC.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
Cleared under the same submission
K902237 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 6142014d-4c50-424d-b330-4a9bb8139693 36 fields · synced May 30, 2026