QuikCoag Control Level 2 Low Abnormal

GUDID 10627944000070

Biomedica Diagnostics Inc

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

• Primary Device ID: 10627944000070
• NIH Device Record Key: 813e7d9c-c254-4ae4-8f6f-20c12652ec51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuikCoag Control Level 2 Low Abnormal
• Version Model Number: 1 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	00627944000073 [Primary]
GS1	10627944000070 [Package]; Contains: 00627944000073; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022046

FDA Product Code

• GGN: Plasma, Coagulation Control

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

Devices Manufactured by Biomedica Diagnostics Inc

• 00627944000011 - QuikCoag PT-HS: 2020-02-24
• 00627944000028 - QuikCoag PT-HS: 2020-02-24
• 10627944000032 - QuikCoag PT-HS: 2020-02-24
• 00627944000042 - QuikCoag APTT-EA: 2020-02-24
• 00627944000059 - QuikCoag APTT-EA: 2020-02-24
• 10627944000063 - QuikCoag Control Level 1 Normal: 2020-02-24
• 10627944000070 - QuikCoag Control Level 2 Low Abnormal: 2020-02-24
• 10627944000070 - QuikCoag Control Level 2 Low Abnormal: 2020-02-24
• 10627944000087 - QuikCoag Control Level 3 High Abnormal: 2020-02-24