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Lupotek Correctin Vl, Lupotek Detectin Vl, Plasmacon La

FDA 510(k)FDA UDIEUDAMED

Class I (US FDA 510(k))

510(k) K083878Ref 86-201

by R2 Diagnostics, Inc.

Identity

Trade Name
LupoTek Correctin VL EUDAMEDFDA UDI
Generic Name
Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Device Name
LupoTek Correctin VL EUDAMED
Venom Confirmatory test for LA 10 x 1 ml FDA UDI
Model / Reference
86-201 EUDAMEDFDA UDI
Description
Venom Confirmatory test for LA 10 x 1 ml FDA UDI

Identifiers

Catalog Number
86-201 FDA UDI
Primary DI / UDI-DI
10859394006115 EUDAMEDFDA UDI
Basic UDI-DI
B-10859394006115 EUDAMED
510(k) Number
K083878 FDA 510(k)FDA UDI
FDA Product Code
GIR FDA 510(k)FDA UDI
GGC FDA UDI
EMDN Code
W0103020606 LUPUS ANTICOAGULANT EUDAMED
GMDN Term
Lupus anticoagulant marker IVD, kit, clotting FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 864.8950 FDA 510(k)
Regulation Number
864.8950 FDA 510(k)FDA UDI
864.5425 FDA UDI
Market of Registration
Italy EUDAMED
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Lupotek Correctin Vl, Lupotek Detectin Vl, Plasmacon La by R2 Diagnostics, Inc. — Class I — IVDD, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
R2 Diagnostics, Inc.

Sources (3)

  • FDA 510(k) K083878 24 fields · synced Jul 9, 2026
  • FDA UDI f0a42414-4ae5-4460-bc89-86d341bf5c27 35 fields · synced May 30, 2026
  • EUDAMED 06522022-19e4-42e6-bf76-6a66db56e0e8 61 fields · synced Jul 9, 2026