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Helix Elite™ Molecular Standards: Inactivated Standard
EUDAMEDFDA UDIClass B (EU MDR)
Ref [HE0052N] Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferiModel HE0052N
Identity
- Trade Name
- Helix Elite™ Molecular Standards: Inactivated Standard FDA UDI
- Generic Name
- Borrelia burgdorferi nucleic acid IVD, control FDA UDI
- Device Name
- Helix Elite™ Molecular Standards: Inactivated Standard EUDAMEDHelix Elite™ Molecular Standards Inactivated Borrelia burgdorferi FDA UDI
- Model / Reference
- HE0052N EUDAMEDFDA UDI[HE0052N] Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferi EUDAMED
- Description
- Helix Elite™ Molecular Standards Inactivated Borrelia burgdorferi FDA UDI
Identifiers
- Catalog Number
- HE0052N FDA UDI
- Primary DI / UDI-DI
- 10845357042672 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453570HE0052NYZ EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
- GMDN Term
- Borrelia burgdorferi 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 | 08453570HE0052NYZ | 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 0d703fc0-4675-4051-b5b1-1019a19be1c2 61 fields · synced Jun 8, 2026
- FDA UDI de60ea44-0872-41d7-a690-637c6f80c5d3 36 fields · synced May 29, 2026