Coagulation Control Level 1 (Normal)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K984129 ↗

FDA Product Code

GIZ

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Prothrombin Reference Plasma (Human)

  Class II

  FDA 510(k) K791022 Active Cleared 24 Jul 1979

• Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)

  Class II

  FDA 510(k) K972627 Active Cleared 13 Aug 1997

• Thrombostrate Control Plasmas

  Class II

  FDA 510(k) K000679 Active Cleared 24 Mar 2000

• Thromboscreen Thromboplastin-Ds

  Class II

  FDA 510(k) K940082 Active Cleared 14 Feb 1995

• Antithrombin III Screen Kit

  Class II

  FDA 510(k) K812215 Active Cleared 1 Sep 1981

• Thromboscreen Aptt Reagent

  Class II

  FDA 510(k) K891337 Active Cleared 21 Apr 1989

See all devices from Pacific Hemostasis →

• What is the Coagulation Control Level 1 (Normal) used for?

  It is intended to provide accurate and reproducible confirmation of coagulation test system performance by verifying normal patient result ranges on coagulation analyzers for tests including PT, APTT, fibrinogen, thrombin time and INR.

• How is the Coagulation Control Level 1 (Normal) supplied and is it sterile?

  The control is supplied as a lyophilized kit containing 10 vials of 1 mL each, is sterile, and is intended for single‑use testing to ensure reliable performance verification.

• What coagulation tests can be assessed using this control?

  It can be run on most coagulation systems to assess performance of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time, and international normalized ratio (INR).

• What storage conditions are required for the Coagulation Control Level 1 (Normal)?

  The product must be stored according to the manufacturer’s instructions to maintain stability, as specified in the labeling for this lyophilized human plasma control.

• Is the Coagulation Control Level 1 (Normal) reusable after reconstitution?

  No, it is intended for single‑use testing only; each vial should be used once and then discarded to prevent contamination and ensure accurate quality control results.