CRYOcheck Factor VIII Chromogenic CCCF08

GUDID 00843876000602

CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. 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

Precision Biologic Inc

Coagulation factor VIII IVD, kit, chromogenic

• Primary Device ID: 00843876000602
• NIH Device Record Key: d6fc3f88-69c3-4db5-a5ea-00acff312426
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRYOcheck Factor VIII Chromogenic
• Version Model Number: CCCF08
• Catalog Number: CCCF08
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843876000602 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251440

FDA Product Code

• GGP: Test, Qualitative And Quantitative Factor Deficiency

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: 2025-12-03
• Device Publish Date: 2025-11-25

On-Brand Devices [CRYOcheck Factor VIII Chromogenic]

• 00843876000558: CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determinati
• 00843876000602: CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determinati