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Anti-streptolysin O Assay Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH090106Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH090107Model R1: 60 mL×1; R2: 15 mL×1Ref DTSH090108Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH090111Model R1: 80 mL×4; R2: 80 mL×1Ref DTSH090105Model R1: 20 mL×1; R2: 5 mL×1
Identity
- Device Name
- Anti-streptolysin O Assay Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH090106 EUDAMEDR1: 60 mL×1; R2: 15 mL×1 EUDAMEDDTSH090107 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH090108 EUDAMEDR1: 80 mL×4; R2: 80 mL×1 EUDAMEDDTSH090111 EUDAMEDR1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH090105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225461766 EUDAMED06975225461773 EUDAMED06975225461780 EUDAMED06975225461827 EUDAMED06975225461759 EUDAMED
- Basic UDI-DI
- B-06975225461766 EUDAMEDB-06975225461773 EUDAMEDB-06975225461780 EUDAMEDB-06975225461827 EUDAMEDB-06975225461759 EUDAMED
- EMDN Code
- W01021104 ANTI-STREPTOLYSIN O (QUANTITATIVE) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Anti-streptolysin O Assay Kit (Immunoturbidimetric Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975225461766 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (5)
- EUDAMED b7ca21f7-de33-4aef-a456-d8a9cc79644d 61 fields · synced Aug 2, 2026
- EUDAMED b080c234-f8d0-457b-874f-ff233aee5f0b 61 fields · synced May 16, 2026
- EUDAMED aedf0615-142e-4261-900e-58ebb89373d8 61 fields · synced May 17, 2026
- EUDAMED 1301ec16-2092-4dda-897d-27696939ed97 61 fields · synced May 17, 2026
- EUDAMED b421dc91-d98b-4598-87a8-1aed864e45e9 61 fields · synced May 19, 2026