Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Rat (Kidney + Liver + Stomach) + Crithidia luciliae 6 Well Slide (each) FDA UDI
- Model / Reference
- 0834 FDA UDI
- Description
- Rat (Kidney + Liver + Stomach) + Crithidia luciliae 6 Well Slide (each) FDA UDI
Identifiers
- Catalog Number
- 0834 FDA UDI
- Primary DI / UDI-DI
- 00813545026875 FDA UDI
- 510(k) Number
- K831100 FDA UDI
- FDA Product Code
- DBL FDA UDI
- GMDN Term
- Smooth muscle 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassayMitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassaySmooth muscle antibody IVD, kit, fluorescent immunoassayIntrinsic factor/parietal cell 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 Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay.
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- NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K831100 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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 4313b21d-9f2a-4161-bb30-540182027883 36 fields · synced Jun 1, 2026