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Precision Biologic

US

Last updated May 23, 2026

What Precision Biologic makes

Precision Biologic manufactures in vitro diagnostic (IVD) reagents, controls, and clotting kits for coagulation testing, including multiple coagulation factor assays, lupus anticoagulant markers, prothrombin time (PT), and activated partial thromboplastin time (APTT). Their products are designed for laboratory use to measure coagulation factors such as Factor VIII, Factor IX, and Factor XII, as well as to detect lupus anticoagulant activity. Examples include chromogenic reagents, deficient plasma controls, and specialized clotting kits for diagnostic evaluation.

The company’s portfolio includes devices classified as Class I and Class II under regulatory frameworks, with products listed via FDA pathways such as the 510(k) and UDI requirements. These diagnostics are intended for use in clinical laboratories to support diagnostic decision-making for coagulation disorders. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Precision Biologic manufacture?

Precision Biologic specializes in in vitro diagnostic (IVD) products used in coagulation testing. Their portfolio includes reagents, controls, and clotting kits for assays like multiple coagulation factors, lupus anticoagulant markers, prothrombin time (PT), and activated partial thromboplastin time (APTT). These products are designed to help laboratories measure specific clotting factors (such as Factor VIII, IX, or XII) and detect lupus anticoagulant activity, aiding in the diagnosis of bleeding and clotting disorders.

Where is Precision Biologic based, and what regulatory frameworks apply to its devices?

Precision Biologic is based in the United States. Their devices fall under FDA regulatory oversight, with classifications ranging from Class I to Class II. Many of their products are listed via the FDA’s 510(k) pathway and comply with Unique Device Identifier (UDI) requirements, ensuring traceability and regulatory compliance for in vitro diagnostics used in clinical settings.

Which regulatory registries or databases list Precision Biologic’s devices?

Precision Biologic’s devices are listed in the FDA’s 510(k) premarket notification database and comply with UDI (Unique Device Identifier) requirements. These registries ensure transparency and traceability of their IVD products, which are intended for laboratory use in coagulation testing. The listings reflect individual device authorizations rather than company-wide approvals.

How are Precision Biologic’s coagulation testing devices classified under regulatory standards?

Precision Biologic’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the complexity of its design, such as whether it involves clotting assays or reagent-based diagnostics.

What is the primary purpose of Precision Biologic’s lupus anticoagulant marker products?

Precision Biologic’s lupus anticoagulant marker products, such as controls, reagents, and clotting kits, are designed to detect and evaluate lupus anticoagulant activity in patient samples. Lupus anticoagulants are antibodies that can interfere with coagulation tests, potentially leading to misdiagnosis of bleeding disorders. These products help laboratories accurately identify and monitor lupus anticoagulant presence, supporting precise diagnostic decisions for conditions like antiphospholipid syndrome.

AI-generated from registry data and not verified by a human reviewer.

Information

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US
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Catalogue (67)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
CRYOcheck Chromogenic Factor IX CCCF09
FDA UDI
Class IIActive
CRYOcheck™ Factor IX Deficient Plasma FDP09-10
FDA UDI
Class IIActive
CRYOcheck™ LA Sure™ SUR-10
FDA UDI
Class IActive
CRYOcheck™ LA Check™ CHK-10
FDA UDI
Class IActive
CRYOcheck Hex LA HEXLA-M
FDA UDI
Class IIActive
CRYOcheck™ Abnormal 1 Control CCA1-10
FDA UDI
Class IIActive
CRYOcheck™ Factor IX Deficient Plasma FDP09-15
FDA UDI
Class IIActive
CRYOcheck™ Weak Lupus Positive Control CCWLP-10
FDA UDI
Class IIActive
CRYOcheck™ Abnormal 1 Reference Control ARP1-10
FDA UDI
Class IIActive
CRYOcheck Factor VIII Deficient Plasma with VWF FDP08VWF
FDA UDI
Class IIActive
CRYOcheck™ Factor XII Deficient Plasma FDP12-10
FDA UDI
Class IIActive
CRYOcheck™ LA Check™ CHK80-10
FDA UDI
Class IActive
CRYOcheck™ Abnormal 2 Control CCA2-10
FDA UDI
Class IIActive
CRYOcheck™ Clot S™ CCS-30
FDA UDI
Class IIUnknown
CRYOcheck™ Factor VII Deficient Plasma FDP07-15
FDA UDI
Class IIActive
CRYOcheck™ Platelet Lysate PNP-10
FDA UDI
Class IIActive
CRYOcheck Factor VIII Deficient Plasma with VWF FDP08VWF
FDA UDI
Class IIActive
CRYOcheck™ Normal Reference Plasma CCNRP-10
FDA UDI
Class IIActive
CRYOcheck Hex LA Hex LA
FDA UDI
Class IIActive
CRYOcheck Hex LA Hex LA-7
FDA UDI
Class IIActive
CRYOcheck™ Abnormal 2 Reference Control ARP2-10
FDA UDI
Class IIActive
CRYOcheck™ LA Check™ CHK50-30
FDA UDI
Class IActive
CRYOcheck™ Factor X Deficient Plasma FDP10-15
FDA UDI
Class IIActive
CRYOcheck™ APCR Positive Control APCR-05
FDA UDI
Class IIActive
CRYOcheck™ Clot S™ CCS-15
FDA UDI
Class IIUnknown
CRYOcheck™ Normal Reference Plasma CCNRP-05
FDA UDI
Class IIActive
CRYOcheck™ Reference Control Normal RCN-10
FDA UDI
Class IIActive
CRYOcheck™ Reference Control Normal RCN-05
FDA UDI
Class IIActive
CRYOcheck™ Pooled Normal Plasma CCN-15
FDA UDI
Class IIActive
CRYOcheck™ Clot C™ CCC-30
FDA UDI
Class IIActive
CRYOcheck™ Factor XI Deficient Plasma FDP11-10
FDA UDI
Class IIActive
C & S Diluent CSD
FDA UDI
Class IIActive
CRYOcheck™ Factor II Deficient Plasma FDP02-15
FDA UDI
Class IIActive
CRYOcheck™ Factor VIII Deficient Plasma FDP08-10
FDA UDI
Class IIActive
CRYOcheck Lupus Negative Control CCLN-05
FDA UDI
Class IIActive
CRYOcheck™ Pooled Normal Plasma CCN-40
FDA UDI
Class IIActive
CRYOcheck™ Clot C™ CCC-15
FDA UDI
Class IIActive
CRYOcheck™ Factor VIII Deficient Plasma FDP08-15
FDA UDI
Class IIActive
CRYOcheck Factor VIII Chromogenic CCCF08
FDA UDI
Class IIActive
CRYOcheck™ Lupus Positive Control CCLP-05
FDA UDI
Class IIActive
CRYOcheck™ Weak Lupus Positive Control CCWLP-05
FDA UDI
Class IIActive
CRYOcheck™ FVIII Inhibitor Kit CCIK08
FDA UDI
Class IIActive
CRYOcheck™ Factor VIII Deficient Plasma FDP08-40
FDA UDI
Class IIActive
CRYOcheck™ Abnormal 1 Reference Control ARP1-05
FDA UDI
Class IIActive
CRYOcheck™ Prekallikrein Deficient Plasma FDPK-10
FDA UDI
Class IIActive
CRYOcheck™ Factor V Deficient Plasma FDP05-10
FDA UDI
Class IIActive
CRYOcheck Lupus Negative Control CCLN-10
FDA UDI
Class IIActive
CRYOcheck™ Factor X Deficient Plasma FDP10-10
FDA UDI
Class IIActive
CRYOcheck™ Factor V Deficient Plasma FDP05-15
FDA UDI
Class IIActive
CRYOcheck™ Pooled Normal Plasma CCN10-10
FDA UDI
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Precision Biologic Inc CA