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Helix Elite™ Molecular Standards: Inactivated Standard
EUDAMEDFDA UDIClass B (EU MDR)
Ref [HE0028N] Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain LongModel HE0028N
Identity
- Trade Name
- Helix Elite™ Molecular Standards: Inactivated Standard FDA UDI
- Generic Name
- Multiple-genus respiratory virus nucleic acid IVD, control FDA UDI
- Device Name
- Helix Elite™ Molecular Standards: Inactivated Standard EUDAMEDHelix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long FDA UDI
- Model / Reference
- HE0028N EUDAMEDFDA UDI[HE0028N] Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long EUDAMED
- Description
- Helix Elite™ Molecular Standards Inactivated Respiratory Syncytial Virus A Strain Long FDA UDI
Identifiers
- Catalog Number
- HE0028N FDA UDI
- Primary DI / UDI-DI
- 10845357042023 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453570HE0028NZ4 EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080804 OTHER VIROLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Multiple-genus respiratory virus 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Helix Elite™ Molecular Standards: Inactivated Standard by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 08453570HE0028NZ4 | 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 5357e8d4-53aa-4d94-9f92-96df6aa99786 61 fields · synced Jul 17, 2026
- FDA UDI a036d9a4-c918-437e-a041-0187f6a01594 36 fields · synced May 30, 2026