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Dade® Innovin®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 10445705Model IVDR_27_MAR EB_C_PROF_REAG_Innovin

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
Dade Innovin EUDAMED
Dade® Innovin® FDA UDI
Generic Name
Prothrombin time (PT) IVD, reagent FDA UDI
Device Name
IVDR_27_MAR EB_C_PROF_REAG_Innovin EUDAMED
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma FDA UDI
Model / Reference
10445705 EUDAMEDFDA UDI
IVDR_27_MAR EB_C_PROF_REAG_Innovin EUDAMED
Description
For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma FDA UDI

Identifiers

Catalog Number
B4212-40 FDA UDI
Primary DI / UDI-DI
00842768003790 EUDAMEDFDA UDI
Basic UDI-DI
0405686900172UZ EUDAMED
Unit of Use DI
00842768019593 EUDAMED
510(k) Number
K974343 FDA UDI
FDA Product Code
GJS FDA UDI
EMDN Code
W0103020101 PROTHROMBIN TIME ( QUICK TEST ) EUDAMED
GMDN Term
Prothrombin time (PT) IVD, reagent FDA UDI

Classification

Device Class
Class C EUDAMED
Class II FDA UDI
Regulation Number
864.7750 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
Not 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

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

Dade® Innovin® by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K974343 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (2)

  • FDA UDI 83e02585-cb85-4d63-a36e-684ae5fbe928 38 fields · synced Oct 8, 2026
  • EUDAMED 491c03c0-9ddf-4821-9427-488ae8ece6e5 61 fields · synced Oct 8, 2026