← Back to catalogue

rheumajet ASO

EUDAMEDFDA UDI

Class B (EU MDR)

Ref 3000-7010

by Biokit S.A.

Identity

Trade Name
rheumajet ASO EUDAMED
Rheumajet ASO 100 TESTS FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI
Device Name
rheumajet ASO EUDAMED
2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES FDA UDI
Model / Reference
3000-7010 EUDAMEDFDA UDI
Description
2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES FDA UDI

Identifiers

Primary DI / UDI-DI
08426950457305 EUDAMEDFDA UDI
Basic UDI-DI
84269504573058F EUDAMED
FDA Product Code
GTQ FDA UDI
EMDN Code
W01021105 ANTI-STREPTOLYSIN O REACTION TIME / TITRE (QUALITATIVE) EUDAMED
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator FDA UDI

Classification

Device Class
Class B EUDAMED
Class I FDA UDI
Regulation Number
866.3720 FDA UDI
Market of Registration
Spain EUDAMED
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

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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

rheumajet ASO by Biokit, S.a. — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biokit S.A.
EUDAMED SRN
ES-MF-000002406

Sources (2)

  • EUDAMED 1fbbef79-df17-411a-8a0b-a6e6b6985c14 61 fields · synced Jul 8, 2026
  • FDA UDI b5ba4884-7923-4ff6-b990-b47114f64dd6 35 fields · synced May 30, 2026