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MeDiCa

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
MeDiCa FDA UDI
Generic Name
Smooth muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Multi-Ab III Rat (Kidney + Stomach) 400 Test Kit FDA UDI
Model / Reference
8021-400 FDA UDI
Description
Multi-Ab III Rat (Kidney + Stomach) 400 Test Kit FDA UDI

Identifiers

Catalog Number
8021-400 FDA UDI
Primary DI / UDI-DI
00813545027261 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

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: 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

A comprehensive guide to the MeDiCa medical device, including its features, compliance, and FAQs.

Similar devices

Also classified as Intrinsic factor/parietal cell antibody IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K831100 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scimedx Corp.

Sources (1)

  • FDA UDI 9cea0c8d-5c29-4b2b-ba62-895efd3e7fef 36 fields · synced Jul 25, 2026