QuikCoag APTT-EA

GUDID 00627944000042

Biomedica Diagnostics Inc

Activated partial thromboplastin time (APTT) IVD, reagent Activated partial thromboplastin time (APTT) IVD, reagent

• Primary Device ID: 00627944000042
• NIH Device Record Key: e8dcb451-ee14-4474-9142-13110cd171f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikCoag APTT-EA
• 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	00627944000042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022021

FDA Product Code

• GFO: Activated Partial Thromboplastin

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 APTT-EA]

• 00627944000059: 10 mL
• 00627944000042: 4 mL