Identity
- Trade Name
- ACCUPROBE® FDA UDI
- Generic Name
- Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Detection Reagent Kit. FDA UDI
- Model / Reference
- KIT DETECTION RGT (CE) FDA UDI
- Description
- Detection Reagent Kit. FDA UDI
Identifiers
- Catalog Number
- 201791 FDA UDI
- Primary DI / UDI-DI
- 15420045506459 FDA UDI
- FDA Product Code
- LQF FDA UDI
- GMDN Term
- Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3370 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
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: Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT)
Accuprobe® by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mycobacterium tuberculosis nucleic acid IVD, kit, nucleic acid technique (NAT).
- ACCUPROBE® — 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 5d08a4ba-65d5-4fe0-9515-eaa9dc2a55c7 36 fields · synced Jun 8, 2026