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Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric)

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref R1:48mL×2 R2:12mL×2(705)

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric) EUDAMED
BIOBASE FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent FDA UDI
Device Name
Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric) EUDAMED
Model / Reference
R1:48mL×2 R2:12mL×2(705) EUDAMED
R1:48mL×2 R2:12mL×2 FDA UDI

Identifiers

Primary DI / UDI-DI
06971674867104 EUDAMEDFDA UDI
Basic UDI-DI
B-06971674867104 EUDAMED
FDA Product Code
GTQ FDA UDI
EMDN Code
W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
GMDN Term
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
866.3720 FDA UDI
Market of Registration
Germany 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

No

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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Anti-Streptolysin O (ASO) Test Kit (Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (2)

  • EUDAMED 15f18f61-8fc2-4cb3-8a5e-cf350d279e57 61 fields · synced Oct 6, 2026
  • FDA UDI 4889290f-140d-4587-b877-f1448a8c6103 32 fields · synced May 29, 2026