CRYOcheck Factor VIII Deficient Plasma with VWF FDP08VWF-15

GUDID 00843876010564

CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% sodium citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying Factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use. CRYOcheck Factor VIII Deficient Plasma with VWF is normal human citrated plasma which has been immunodepleted of factor VIII and which contains normal levels of von Willebrand Factor (VWF), buffered with HEPES. Factor VIII has been assayed at less than 1% of normal antigen and activity levels while VWF antigen and activity levels are >50%. Device is provided frozen as 25 vials of 1.0 mL

Precision Biologic Inc

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• Primary Device ID: 00843876010564
• NIH Device Record Key: 3e461d29-ccc6-40d9-ae5d-9b137d9d1f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck Factor VIII Deficient Plasma with VWF
• Version Model Number: FDP08VWF
• Catalog Number: FDP08VWF-15
• Company DUNS: 244713368
• Company Name: Precision Biologic Inc
• Device Count: 25
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000589 [Primary]
GS1	00843876010564 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222831

FDA Product Code

• GJT: Plasma, Coagulation Factor Deficient

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: 2023-10-03
• Device Publish Date: 2023-09-25

On-Brand Devices [CRYOcheck Factor VIII Deficient Plasma with VWF]

• 00843876010564: CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient su
• 00843876010557: CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient su