← Back to catalogue
S100 Assay Kit (Chemiluminescent Immunoassay)
EUDAMEDClass IVD General (EU MDR)
Ref DI0101Model 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2
Identity
- Trade Name
- S100 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Device Name
- S100 Assay Kit (Chemiluminescent Immunoassay) EUDAMED
- Model / Reference
- 2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2 EUDAMEDDI0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942028503092 EUDAMED
- Basic UDI-DI
- B-06942028503092 EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
S100 Assay Kit (Chemiluminescent Immunoassay) by Sichuan Orienter Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
- PRAME [EPR20330] — BIOCARE MEDICAL, LLC · Class I
- Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14] — Sakura Finetek USA, Inc · Class C
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class C
- PG II Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class C
- iFlash-Total β HCG — SHENZHEN YHLO BIOTECH CO., LTD. · Class C
- PG I Rapid Quantitative Test (Chemiluminescence Immunoassay) — Xiamen Biotime Biotechnology Co., Ltd. · IVD General
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-06942028503092 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sichuan Orienter Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000003026
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 39182dfa-7b73-4710-9869-e296c33d5670 61 fields · synced Jul 8, 2026