CRYOcheck™ FVIII Inhibitor Kit

GUDID 00843876000503

The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older.

Precision Biologic Inc

Coagulation factor VIII inhibitor IVD, control

• Primary Device ID: 00843876000503
• NIH Device Record Key: 9b813cec-1d47-4b0a-892c-f20a282ff9bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ FVIII Inhibitor Kit
• Version Model Number: CCIK08
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183440

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-02
• Device Publish Date: 2019-03-25

Devices Manufactured by Precision Biologic Inc

• 00843876010557 - CRYOcheck Factor VIII Deficient Plasma with VWF: 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
• 00843876010564 - CRYOcheck Factor VIII Deficient Plasma with VWF: 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete
• 00843876000596 - CRYOcheck Hex LA: 2023-05-10 CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulan
• 00843876000558 - CRYOcheck Factor VIII Chromogenic: 2020-08-04 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.
• 00843876000534 - CRYOcheck Lupus Negative Control: 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
• 00843876000541 - CRYOcheck Lupus Negative Control: 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant.
• 00843876000503 - CRYOcheck™ FVIII Inhibitor Kit: 2019-04-02The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older.
• 00843876000503 - CRYOcheck™ FVIII Inhibitor Kit: 2019-04-02 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable perf
• 00843876000015 - CRYOcheck™ Pooled Normal Plasma: 2018-07-06