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Helix Elite™ Molecular Standards: Synthetic Standard
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Helix Elite™ Molecular Standards: Synthetic Standard FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
- Device Name
- Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA FDA UDI
- Model / Reference
- HE0013S FDA UDI
- Description
- Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA FDA UDI
Identifiers
- Catalog Number
- HE0013S FDA UDI
- Primary DI / UDI-DI
- 10845357041859 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards: Synthetic Standard by Microbiologics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, control.
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- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class II
- Helix Elite Molecular Standards — MICROBIOLOGICS, INC. · Class I
- Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, Inc.
Sources (1)
- FDA UDI 60c962b9-a294-4440-8d42-f4a0c848ef2b 36 fields · synced May 31, 2026