Identity
- Trade Name
- QC Sets and Panels: Helix Elite™ FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
- Device Name
- BD MAX™ Enteric Parasite 20-Day QC Panel FDA UDI
- Model / Reference
- 8202 BD MAX™ Enteric Parasite 20-Day QC Panel FDA UDI
- Description
- BD MAX™ Enteric Parasite 20-Day QC Panel FDA UDI
Identifiers
- Catalog Number
- 8202 FDA UDI
- Primary DI / UDI-DI
- 70845357041097 FDA UDI
- 510(k) Number
- K181711 FDA UDI
- FDA Product Code
- PMN FDA UDI
- GMDN Term
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 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
Yes
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
No
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
QC Sets and Panels: Helix Elite™ by Microbiologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, control.
- EasyScreen™ Gastrointestinal Parasite PCR Positive Control — Genetic Signatures Limited · Class II
- NATtrol™ — ZeptoMetrix LLC · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- 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
Cleared under the same submission
K181711 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Microbiologics, Inc.
Sources (1)
- FDA UDI 8bfe482e-9977-4fbc-86a3-b55da840f3e1 37 fields · synced Jun 8, 2026