Identity
- Trade Name
- Hologic FDA UDI
- Generic Name
- Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- NG Res Probe (FAM) Analyte Specific Reagent. FDA UDI
- Model / Reference
- RNA, NG RES PROBE (ASR) FDA UDI
- Description
- NG Res Probe (FAM) Analyte Specific Reagent. FDA UDI
Identifiers
- Catalog Number
- PRD-08445 FDA UDI
- Primary DI / UDI-DI
- 15420045517400 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Hologic by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-genus sexually transmitted bacteria nucleic acid IVD, kit, nucleic acid technique (NAT).
- Hologic — Hologic, Inc. · Class I
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
- Hologic, Inc.
Sources (1)
- FDA UDI 94c841d4-89d2-413e-a9dd-ddc958564280 36 fields · synced May 30, 2026