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 ID10629009121102
NIH Device Record Key50d2f28c-3ef6-496d-92e3-6d2bd7e3ba9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisuCon-L(TM) Abnormal Control Plasma
Version Model NumberLYABP01
Company DUNS249373515
Company NameAffinity Biologicals Inc
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com
Phone1-800-903-6020
Emailinfo@affinitybiologicals.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110629009120013 [Unit of Use]
GS110629009121102 [Primary]

FDA Product Code

GGNPlasma, Coagulation Control

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-30
Device Publish Date2019-10-22

Devices Manufactured by Affinity Biologicals Inc

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10629009121102 - VisuCon-L(TM) Abnormal Control Plasma2019-10-30A 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 Plasma2019-10-30 A pool of citrated normal human plasma collected from a minimum of 20 donors, and diluted to defined concentrations. Plasma is b
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