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Coombscell-E

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Medical Diagnostics GmbH

Identity

Trade Name
Coombscell-E FDA UDI
Generic Name
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI
Device Name
IgG-coated red blood cells for the control of antiglobulin test; 10ml FDA UDI
Model / Reference
816030100 FDA UDI
Description
IgG-coated red blood cells for the control of antiglobulin test; 10ml FDA UDI

Identifiers

Catalog Number
816030100 FDA UDI
Primary DI / UDI-DI
07611969952502 FDA UDI
FDA Product Code
KSF FDA UDI
GMDN Term
Immunoglobulin-sensitized reagent red blood cell IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9650 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Immunoglobulin-sensitized reagent red blood cell IVD, control

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

Similar devices

Also classified as Immunoglobulin-sensitized reagent red blood cell IVD, control.

Cleared under the same submission

BK080012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Medical Diagnostics GmbH

Sources (1)

  • FDA UDI a2b1b652-9ec8-472c-be36-f839f32b85de 37 fields · synced Jun 8, 2026