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QC Sets and Panels: Helix Elite™
EUDAMEDFDA UDIClass B (EU MDR)
Ref [8209] QC Sets and Panels: Helix Elite™ Vaginal Control PanelModel 8209
Identity
- Trade Name
- QC Sets and Panels: Helix Elite™ FDA UDI
- Generic Name
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI
- Device Name
- QC Sets and Panels: Helix Elite™ EUDAMEDQC Sets and Panels: Helix Elite™ Vaginal Control Panel FDA UDI
- Model / Reference
- 8209 EUDAMEDFDA UDI[8209] QC Sets and Panels: Helix Elite™ Vaginal Control Panel EUDAMED
- Description
- QC Sets and Panels: Helix Elite™ Vaginal Control Panel FDA UDI
Identifiers
- Catalog Number
- 8209 FDA UDI
- Primary DI / UDI-DI
- 70845357041325 EUDAMEDFDA UDI
- Basic UDI-DI
- 084535708209B8 EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- France 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
Yes
EUDAMED
Reagent
No
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
No
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
QC Sets and Panels: Helix Elite™ by Microbiologics, Inc. — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 084535708209B8 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED a54eb1d5-d2fc-4b0b-8f83-01c8392f89c6 61 fields · synced Jun 8, 2026
- FDA UDI b81cd210-9aca-4564-a2ec-976bf630bb3b 36 fields · synced May 30, 2026