← Back to catalogue

IH-Titration Solution

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
IH-Titration Solution FDA UDI
Generic Name
Red cell antibody diluent IVD, reagent FDA UDI
Device Name
IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with appropriate IH-Cards. FDA UDI
Model / Reference
813560100 FDA UDI
Description
IH-Titration Solution is a dilution medium for the titer determination of antibodies in patient and donor samples for use with appropriate IH-Cards. FDA UDI

Identifiers

Catalog Number
813560100 FDA UDI
Primary DI / UDI-DI
07611969952205 FDA UDI
FDA Product Code
KSG FDA UDI
GMDN Term
Red cell antibody diluent IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9600 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Red cell antibody diluent IVD, reagent

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

Similar devices

Also classified as Red cell antibody diluent IVD, reagent.

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 3347230d-037f-4c97-b9a2-9d6eb1d06a7e 36 fields · synced May 30, 2026