← Back to catalogue

CRYOcheck™ Pooled Normal Plasma

FDA UDI

Class II (US FDA UDI)

by Precision Biologic

Identity

Trade Name
CRYOcheck™ Pooled Normal Plasma FDA UDI
Generic Name
Multiple coagulation factor IVD, reagent FDA UDI
Model / Reference
CCN-40 FDA UDI

Identifiers

Primary DI / UDI-DI
00843876000046 FDA UDI
510(k) Number
K922887 FDA UDI
FDA Product Code
GGN FDA UDI
GMDN Term
Multiple coagulation factor IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 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, reagentProthrombin time (PT) IVD, controlActivated partial thromboplastin time (APTT) IVD, control

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

Similar devices

Also classified as Activated partial thromboplastin time (APTT) IVD, control.

Cleared under the same submission

K922887 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Precision Biologic

Sources (1)

  • FDA UDI 4a715250-6e26-4008-817d-58079bb754be 33 fields · synced May 30, 2026