Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- ASMA (anti-smooth muscle) Mouse Stomach 48 Test Kit FDA UDI
- Model / Reference
- 4001-48-M FDA UDI
- Description
- ASMA (anti-smooth muscle) Mouse Stomach 48 Test Kit FDA UDI
Identifiers
- Catalog Number
- 4001-48-M FDA UDI
- Primary DI / UDI-DI
- 00813545027018 FDA UDI
- 510(k) Number
- K790430 FDA UDI
- FDA Product Code
- DBE FDA UDI
- GMDN Term
- Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5120 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: Smooth muscle antibody IVD, kit, fluorescent immunoassay
MeDiCa by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Smooth muscle antibody IVD, kit, fluorescent immunoassay.
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Cleared under the same submission
K790430 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 67b40194-c80d-4be9-bcb0-0fb29839d81c 36 fields · synced May 30, 2026