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Asserachrom® IX:Ag

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 00943

by Diagnostica Stago

Identity

Trade Name
Asserachrom® IX:Ag EUDAMEDFDA UDI
Generic Name
Coagulation factor IX IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Asserachrom® IX:Ag EUDAMED
Model / Reference
00943 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03607450009439 EUDAMEDFDA UDI
Basic UDI-DI
B-03607450009439 EUDAMED
510(k) Number
K854312 FDA UDI
FDA Product Code
GGP FDA UDI
EMDN Code
W0103020208 COAGULATION FACTOR IX EUDAMED
GMDN Term
Coagulation factor IX IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class IVD General 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

Yes

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

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

Asserachrom® IX:Ag by Diagnostica Stago — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostica Stago
EUDAMED SRN
FR-MF-000017089

Sources (2)

  • EUDAMED edcd9d6c-9aed-4cc0-abff-070ca22d2116 61 fields · synced Jul 18, 2026
  • FDA UDI c6dbf1e9-1ccb-4752-a67d-f76ed0e6246d 34 fields · synced May 30, 2026