CRYOcheck Chromogenic Factor IX

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name: CRYOcheck Chromogenic Factor IX FDA UDI
Generic Name: Coagulation factor IX IVD, kit, chromogenic FDA UDI
Device Name: CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use FDA UDI
Model / Reference: CCCF09 FDA UDI
Description: CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use FDA UDI

Identifiers

Catalog Number: CCCF09 FDA UDI
Primary DI / UDI-DI: 00843876000565 FDA UDI
510(k) Number: K214002 FDA UDI
FDA Product Code: GGP FDA UDI
GMDN Term: Coagulation factor IX IVD, kit, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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 IX IVD, kit, chromogenic

CRYOcheck Chromogenic Factor IX by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor IX IVD, kit, chromogenic.

HemosIL Chromogenic Factor IX — INSTRUMENTATION LABORATORY COMPANY · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Precision Biologic

Sources (1)

FDA UDI 8c905a33-2dc0-4dd4-89f3-f316c00c4f65 36 fields · synced May 31, 2026