CRYOcheck™ Prekallikrein Deficient Plasma

GUDID 00843876000381

Precision Biologic Inc

Multiple coagulation factor IVD, reagent

• Primary Device ID: 00843876000381
• NIH Device Record Key: 5d9bb86a-6c0b-4690-9d8d-1ba769ea190a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck™ Prekallikrein Deficient Plasma
• Version Model Number: FDPK-10
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000381 [Primary]
GS1	00843876010380 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990296

FDA Product Code

• GJT: Plasma, Coagulation Factor Deficient

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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: 2019-04-02 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