← Back to catalogue

IH-Com

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
IH-Com FDA UDI
Generic Name
Laboratory instrument/analyser application software IVD FDA UDI
Device Name
IH-Com Kit Fullversion US; Software Version: 04.0.27. FDA UDI
Model / Reference
04.0.27 FDA UDI
Description
IH-Com Kit Fullversion US; Software Version: 04.0.27. FDA UDI

Identifiers

Catalog Number
009100 FDA UDI
Primary DI / UDI-DI
03610520569870 FDA UDI
FDA Product Code
KSZ FDA UDI
GMDN Term
Laboratory instrument/analyser application software IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9175 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory instrument/analyser application software IVD

IH-Com by Bio-Rad Medical Diagnostics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory instrument/analyser application software IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI 20f66c8b-98c8-47ae-93bc-cd0d1b164b73 36 fields · synced May 30, 2026