DailyChek QC Kit

FDA UDI

Class II (US FDA UDI)

by American National Red Cross

Identity

Trade Name: DailyChek QC Kit FDA UDI
Generic Name: Multiple immunohaematology test IVD, control FDA UDI
Device Name: Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells. FDA UDI
Model / Reference: 510395 FDA UDI
Description: Blood Bank kit used to perform quality control testing of reverse grouping and screening cell reagent red blood cells. FDA UDI

Identifiers

Primary DI / UDI-DI: 00858400005084 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

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

DailyChek QC Kit by American National Red Cross — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: American National Red Cross

Sources (1)

FDA UDI 47dc9566-5d5c-4f0e-9550-8d468d166625 35 fields · synced May 30, 2026