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VisuCon-L Coag Screen N Plasma

FDA UDI

Class II (US FDA UDI)

by Affinity Biologicals Inc

Identity

Trade Name
VisuCon-L Coag Screen N Plasma FDA UDI
Generic Name
Multiple coagulation factor IVD, control FDA UDI
Device Name
A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range. FDA UDI
Model / Reference
LSCN01 FDA UDI
Description
A pool of normal citrated human plasma collected from a minimum of 20 donors, buffered with 0.05M HEPES buffer and stabilizers, dispensed and lyophilized. This plasma is used for the quality control of coagulation assays (PT, APTT and Fibinogen) in the normal range. FDA UDI

Identifiers

Primary DI / UDI-DI
10629009091108 FDA UDI
FDA Product Code
GGN FDA UDI
GMDN Term
Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5425 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

VisuCon-L Coag Screen N Plasma by Affinity Biologicals Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Affinity Biologicals Inc

Sources (1)

  • FDA UDI e3f6d77e-f5f0-4fb9-a431-c9b1127316ed 36 fields · synced Jun 8, 2026