VisuCon-L(TM) Abnormal Control Plasma

GUDID 10629009121102

A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.

Affinity Biologicals Inc

Multiple coagulation factor IVD, control

• Primary Device ID: 10629009121102
• NIH Device Record Key: 50d2f28c-3ef6-496d-92e3-6d2bd7e3ba9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisuCon-L(TM) Abnormal Control Plasma
• Version Model Number: LYABP01
• Company DUNS: 249373515
• Company Name: Affinity Biologicals Inc
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Customer Support Contacts

• Phone: 1-800-903-6020
• Email: info@affinitybiologicals.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10629009120013 [Unit of Use]
GS1	10629009121102 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control

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: 2019-10-30
• Device Publish Date: 2019-10-22

Devices Manufactured by Affinity Biologicals Inc

• 10629009140516 - Sheep anti-human Factor XIII Analyte Specific Reagent: 2022-10-03 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.
• 10629009145016 - Sheep anti-human Factor XIII Analyte Specific Reagent: 2022-10-03 The specific use of this ASR (Analyte Specific Reagent) will depend upon the end user's application.
• 10629009121102 - VisuCon-L(TM) Abnormal Control Plasma: 2019-10-30A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is buffered with 0.05M HEPES and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays in the normal range, including fibrinogen, coagulation factors II, V, VII, VIII, IX, X XI and XII, ATIII activity, Protein C activity and Protein S activity.
• 10629009121102 - VisuCon-L(TM) Abnormal Control Plasma: 2019-10-30 A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is b
• 10629009131101 - VisuCon-L(TM) Normal Control Plasma: 2019-10-30 A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES and stabilizers, dispens