Identity
- Trade Name
- QC Sets and Panels: Helix Elite™ FDA UDI
- Generic Name
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control FDA UDI
- Device Name
- Assayed GBS LB Control Panel FDA UDI
- Model / Reference
- 8194 Cepheid Xpert® GBS LB Control Panel FDA UDI
- Description
- Assayed GBS LB Control Panel FDA UDI
Identifiers
- Catalog Number
- 8194 FDA UDI
- Primary DI / UDI-DI
- 70845357041219 FDA UDI
- 510(k) Number
- K182472 FDA UDI
- FDA Product Code
- PMN FDA UDI
- GMDN Term
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3920 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
QC Sets and Panels: Helix Elite™ by Microbiologics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Microbiologics, Inc.
Sources (1)
- FDA UDI 5a0070b9-ead1-43d7-83fd-2ecb0d81b761 38 fields · synced Jun 8, 2026