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CRYOcheck™ Factor II Deficient Plasma

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name
CRYOcheck™ Factor II Deficient Plasma FDA UDI
Generic Name
Coagulation factor II (prothrombin) IVD, reagent FDA UDI
Model / Reference
FDP02-10 FDA UDI

Identifiers

Primary DI / UDI-DI
00843876000213 FDA UDI
510(k) Number
K990814 FDA UDI
FDA Product Code
GJT FDA UDI
GMDN Term
Coagulation factor II (prothrombin) IVD, reagent 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Multiple coagulation factor IVD, reagentCoagulation factor II (prothrombin) IVD, reagent

CRYOcheck™ Factor II Deficient Plasma by Precision Biologic — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation factor II (prothrombin) IVD, reagent.

Cleared under the same submission

K990814 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Precision Biologic

Sources (1)

  • FDA UDI 422e9d7d-7a64-4304-a282-892ff12b8384 33 fields · synced May 31, 2026