PlasmaCon LA

FDA UDI

Class II (US FDA UDI)

by R2 Diagnostics, Inc.

Identity

Trade Name: PlasmaCon LA FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Device Name: Positive control for LA 10 x 0.5 ml FDA UDI
Model / Reference: 150-200 FDA UDI
Description: Positive control for LA 10 x 0.5 ml FDA UDI

Identifiers

Catalog Number: 150-200 FDA UDI
Primary DI / UDI-DI: 10859394006122 FDA UDI
510(k) Number: K083878 FDA UDI
FDA Product Code: GGC FDA UDI
GIR FDA UDI
GMDN Term: Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 FDA UDI
864.8950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Multiple coagulation factor IVD, control

PlasmaCon LA by R2 Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K083878 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: R2 Diagnostics, Inc.

Sources (1)

FDA UDI 3d0e98ec-117e-49a8-86b9-b7c973700a93 35 fields · synced Jun 1, 2026