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Helix Elite™ Molecular Standards: Inactivated Standard
EUDAMEDFDA UDIClass B (EU MDR)
Ref [HE0058N] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet)Model HE0058N
Identity
- Trade Name
- Helix Elite™ Molecular Standards: Inactivated Standard FDA UDI
- Generic Name
- PCR/NAT negative control IVD FDA UDI
- Device Name
- Helix Elite™ Molecular Standards: Inactivated Standard EUDAMEDHelix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet) FDA UDI
- Model / Reference
- HE0058N EUDAMEDFDA UDI[HE0058N] Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet) EUDAMED
- Description
- Helix Elite™ Molecular Standards Negative Cellularity Control (Inactivated Pellet) FDA UDI
Identifiers
- Catalog Number
- HE0058N FDA UDI
- Primary DI / UDI-DI
- 10845357043273 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453570HE0058NZK EUDAMED
- FDA Product Code
- OHQ FDA UDI
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
- GMDN Term
- PCR/NAT negative control IVD 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 | 08453570HE0058NZK | 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 e1ab284f-5866-472c-985d-8657d2d2d501 61 fields · synced May 29, 2026
- FDA UDI 527aa647-f60a-492b-8064-ef05849a9c26 36 fields · synced May 29, 2026