QuikCoag PT-HS

GUDID 00627944000028

Biomedica Diagnostics Inc

Prothrombin time (PT) IVD, reagent Prothrombin time (PT) IVD, reagent

• Primary Device ID: 00627944000028
• NIH Device Record Key: 28684bbc-b9ae-4e69-a160-3f8895686e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikCoag PT-HS
• Version Model Number: 4 mL
• Company DUNS: 200152713
• Company Name: Biomedica Diagnostics 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627944000028 [Primary]
GS1	10627944000025 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020840

FDA Product Code

• GJS: Test, Time, Prothrombin

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: 2020-02-24
• Device Publish Date: 2016-09-22

On-Brand Devices [QuikCoag PT-HS]

• 10627944000032: 10 mL
• 00627944000028: 4 mL
• 00627944000011: 2 mL