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MeDiCa

FDA UDI

Class II (US FDA UDI)

by Scimedx Corp.

Identity

Trade Name
MeDiCa FDA UDI
Generic Name
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Rat Liver 4 Well Slide (each) FDA UDI
Model / Reference
0101 FDA UDI
Description
Rat Liver 4 Well Slide (each) FDA UDI

Identifiers

Catalog Number
0101 FDA UDI
Primary DI / UDI-DI
00813545026561 FDA UDI
510(k) Number
K782048 FDA UDI
FDA Product Code
DHN FDA UDI
GMDN Term
Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 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

No

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 immunoassay

MeDiCa by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay.

Cleared under the same submission

K782048 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 114f4ff5-d69b-424a-b0cf-8a428d98fc62 36 fields · synced Jun 8, 2026