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CHRONO-LOG° vW Reference Plasma Deficient

EUDAMEDFDA UDI

Class A (EU MDR)

Ref 299-4 vW Reference Plasma Deficient

by Chrono-log Corp

Identity

Trade Name
CHRONO-LOG° vW Reference Plasma Deficient EUDAMED
Chrono-log FDA UDI
Generic Name
Platelet aggregation study IVD, reagent FDA UDI
Device Name
Reagents EUDAMED
vW Reference Plasma Deficient FDA UDI
Model / Reference
299-4 vW Reference Plasma Deficient EUDAMED
299-4 FDA UDI
Description
vW Reference Plasma Deficient FDA UDI

Identifiers

Primary DI / UDI-DI
00811476010017 EUDAMEDFDA UDI
Basic UDI-DI
081147601Reagents2YY EUDAMED
510(k) Number
K945414 FDA UDI
FDA Product Code
GGP FDA UDI
EMDN Code
W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
GMDN Term
Platelet aggregation study IVD, reagent FDA UDI

Classification

Device Class
Class A EUDAMED
Class II FDA UDI
Regulation Number
864.7290 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

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

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

CHRONO-LOG° vW Reference Plasma Deficient by Chrono-Log Corp — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Chrono-log Corp
EUDAMED SRN
US-MF-000018631
Authorised Representative
BioTop Medical NL-AR-000012565

Sources (2)

  • EUDAMED 06d6c25d-2121-4aa8-88b0-d80b6e50ccc1 61 fields · synced Jul 15, 2026
  • FDA UDI 732d191c-fa6d-4e8f-ac48-db2d75d9aa32 36 fields · synced May 30, 2026