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STA® - Stachrom® Protein C

EUDAMEDFDA UDI

Class B (EU MDR)

Ref 00671

by Diagnostica Stago

Identity

Trade Name
STA® - Stachrom® Protein C EUDAMEDFDA UDI
Generic Name
Protein C IVD, kit, chromogenic FDA UDI
Device Name
STA® - Stachrom® Protein C EUDAMED
Model / Reference
00671 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03607450006711 EUDAMEDFDA UDI
Basic UDI-DI
360745099PC0002ZR EUDAMED
510(k) Number
K931906 FDA UDI
FDA Product Code
GGP FDA UDI
EMDN Code
W0103020607 PROTEIN C EUDAMED
GMDN Term
Protein C IVD, kit, chromogenic FDA UDI

Classification

Device Class
Class B EUDAMED
Class II FDA UDI
Regulation Number
864.7290 FDA UDI
Market of Registration
France 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

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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

STA® - Stachrom® Protein C by Diagnostica Stago — Class B — 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
Diagnostica Stago
EUDAMED SRN
FR-MF-000017089

Sources (2)

  • EUDAMED ffbe8b0e-59c3-4046-a4d8-e7a11c42321a 61 fields · synced Jun 19, 2026
  • FDA UDI ad253f0e-929d-4f26-87ea-502fa0198023 34 fields · synced May 29, 2026