Identity
- Trade Name
- RealTime FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps FDA UDI
- Model / Reference
- 8L07-50 FDA UDI
- Description
- Abbott RealTime CT/NG Amplification Reagent Extended Use with Pierceable Caps FDA UDI
Identifiers
- Catalog Number
- 8L07-50 FDA UDI
- Primary DI / UDI-DI
- 00884999037298 FDA UDI
- 510(k) Number
- K140354 FDA UDI
- FDA Product Code
- LSL FDA UDILIO FDA UDIMKZ FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI866.2900 FDA UDI866.3120 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
RealTime by Abbott Molecular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- Aptima® — Hologic, Inc. · Class I
- Aptima Combo 2® — Hologic, Inc. · Class II
- APTIMA — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Aptima Combo 2® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class I
- Aptima Combo 2® — Hologic, Inc. · Class II
- cobas CTNG Positive Control Kit — Roche Molecular Systems, Inc. · Class II
Cleared under the same submission
K140354 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 |
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Manufacturer
- Manufacturer
- Abbott Molecular
Sources (1)
- FDA UDI a14f4a61-eb93-4850-b7ba-5dc3f35860de 36 fields · synced May 30, 2026