Identity
- Trade Name
- MeDiCa FDA UDI
- Generic Name
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- AMA (anti-mitochondrial) Rat Kidney 48 Test Kit FDA UDI
- Model / Reference
- 3001-48 FDA UDI
- Description
- AMA (anti-mitochondrial) Rat Kidney 48 Test Kit FDA UDI
Identifiers
- Catalog Number
- 3001-48 FDA UDI
- Primary DI / UDI-DI
- 00813545026950 FDA UDI
- 510(k) Number
- K790295 FDA UDI
- FDA Product Code
- DBM FDA UDI
- GMDN Term
- Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5090 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: Mitochondrial antibody M2 (anti-Mi2) 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 Mitochondrial antibody M2 (anti-Mi2) IVD, kit, fluorescent immunoassay.
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- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
- Histofluor® Rodent LKS Fluorescent Antibody Test System — IMMUNO CONCEPTS INC
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- NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach — INOVA DIAGNOSTICS, INC. · Class II
Cleared under the same submission
K790295 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 08cb2428-1a7e-40d7-8903-878ebcb8ceb0 36 fields · synced May 31, 2026