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Genemed®

FDA UDI

Class I (US FDA UDI)

by Sakura Finetek USA, Inc

Identity

Trade Name
Genemed® FDA UDI
Generic Name
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Blocking Solution (Non-immune), Ready-To-Use, 100 mL FDA UDI
Model / Reference
10-0032 FDA UDI
Description
Blocking Solution (Non-immune), Ready-To-Use, 100 mL FDA UDI

Identifiers

Catalog Number
10-0032 FDA UDI
Primary DI / UDI-DI
00615233006998 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)

Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sakura Finetek USA, Inc

Sources (1)

  • FDA UDI fbd5a6f0-f58c-4983-a417-532c926e0805 35 fields · synced May 30, 2026