CRYOcheck™ Normal Reference Plasma CCNRP-10

• FDA 510(k) K952622 decided 30 Oct 1995 Active
• FDA GUDID UDI-DI 00843876000206 listed 23 Sep 2016 Listed

1. 30 Oct 1995 Cleared FDA 510(k) K952622
2. 23 Sep 2016 Listed FDA GUDID 00843876000206

Trade name

CRYOcheck™ Normal Reference Plasma

Generic name

Multiple coagulation marker IVD, calibrator

Model / reference

CCNRP-10

Primary DI / UDI-DI

00843876000206

510(k) Number

K952622 ↗

FDA product code

GGN

GMDN term

Multiple coagulation marker IVD, calibrator

Device class

Class II

Regulation number

864.5425

GUDID distribution status

In Commercial Distribution

Category: Multiple coagulation factor IVD, calibrator

Other devices filed under FDA product code GGN (Plasma, Coagulation Control).

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• CLIBRATION PLASMAS by Behring Diagnostics, Inc.
• Pool Norm by Diagnostics Stago S.A.S.
• LYPHOCHEK HEMOSTASIS CONTROL by Bio-Rad
• COAG-CONTROL [N] KIT by American Bioproducts Co.
• VALIDATE D-Dimer Calibration Verification / Linearity Test Kit by Maine Standards Co.
• HMP CONTROLS (TAS) RAPIDPOINT by Cardiovascular Diagnostics, Inc.
• ROTEM® ROTROL P 503-25-US, 503-25 by Tem Innovations GmbH
• A-FACT, ABNORMAL FACTOR ASSAY CONTROL by GEORGE KING BIO-MEDICAL, INC.

• CRYOcheck Factor VIII Chromogenic CCCF08

  Class II

  FDA 510(k) K251440 Active Cleared 25 Aug 2025 GUDID on market

• CRYOcheck Chromogenic Factor IX CCCF09

  Class II

  FDA 510(k) K214002 Active Cleared 23 Dec 2022 GUDID on market

• CRYOcheck™ Factor IX Deficient Plasma FDP09-10

  Class II

  FDA 510(k) K971226 Active Cleared 18 Jul 1997 GUDID on market

• CRYOcheck™ LA Sure™ SUR-10

  Class I

  FDA 510(k) K990580 Active Cleared 28 Jul 1999 GUDID on market

See all devices from Precision Biologic →