Checkcell (Weak)

FDA UDI

Class II (US FDA UDI)

by Immucor, Inc.

Identity

Trade Name: Checkcell (Weak) FDA UDI
Generic Name: Multiple immunohaematology test IVD, control FDA UDI
Device Name: Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration. FDA UDI
Model / Reference: 0002227 FDA UDI
Description: Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration. FDA UDI

Identifiers

Catalog Number: 0002227 FDA UDI
Primary DI / UDI-DI: 10888234000211 FDA UDI
FDA Product Code: KSF FDA UDI
GMDN Term: Multiple immunohaematology test 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple immunohaematology test IVD, control

Checkcell (Weak) by Immucor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

BK110050 also covers:

Checkcell — IMMUCOR, INC.
Checkcell — IMMUCOR, INC.
Checkcell (Weak) — IMMUCOR, INC.
DAT Positive Control Cell — IMMUCOR, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Immucor, Inc.

Sources (1)

FDA UDI 0edb9104-1f8d-4556-9b24-091b780e87ce 37 fields · synced May 30, 2026