CRYOcheck™ FVIII Inhibitor Kit

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name: CRYOcheck™ FVIII Inhibitor Kit FDA UDI
Generic Name: Coagulation factor VIII inhibitor IVD, control FDA UDI
Device Name: The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. FDA UDI
Model / Reference: CCIK08 FDA UDI
Description: The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. FDA UDI

Identifiers

Primary DI / UDI-DI: 00843876000503 FDA UDI
510(k) Number: K183440 FDA UDI
FDA Product Code: GGN FDA UDI
GGP FDA UDI
GMDN Term: Coagulation factor VIII inhibitor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 FDA UDI
864.7290 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Coagulation factor VIII inhibitor IVD, control Coagulation factor VIII inhibitor IVD, reagent

CRYOcheck™ FVIII Inhibitor Kit by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor VIII inhibitor IVD, control.

George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II
George King Factor VIII Deficient Plasma with Inhibitor — GEORGE KING BIO-MEDICAL, INC. · Class II

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: Precision Biologic

Sources (1)

FDA UDI 9b813cec-1d47-4b0a-892c-f20a282ff9bf 34 fields · synced Jun 8, 2026