Identity
- Trade Name
- APTIMA FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Model / Reference
- AC2, REFRIG, 250T, READY MADE FDA UDI
Identifiers
- Catalog Number
- PRD-07039 FDA UDI
- Primary DI / UDI-DI
- 15420045514973 FDA UDI
- 510(k) Number
- K200436 FDA UDI
- FDA Product Code
- LSL FDA UDIQEP 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 UDI866.3393 FDA UDI866.3120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima is a cutting-edge, multiple-type sexually transmitted pathogen nucleic acid immuno-diagnostics device designed for detecting various microorganisms associated with STIs. With its advanced technology and robust design, Aptima provides accurate and reliable results in clinical settings.
Similar devices
Also classified as Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas CTNG Positive Control Kit — Roche Molecular Systems, Inc. · Class II
- Alinity m — Abbott Molecular · Class II
- Xpert CT/NG — CEPHEID · Class II
- cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems — Roche Molecular Systems, Inc. · Class I
- Savanna — DIAGNOSTIC HYBRIDS, INC. · Class II
- Xpert CT/NG — CEPHEID · Class II
- BD CTGCTV2 — BECTON DICKINSON AND COMPANY · Class I
- RealTime — Abbott Molecular · Class II
Cleared under the same submission
K200436 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Hologic, Inc.
Sources (1)
- FDA UDI 14382dc3-361e-493e-a1de-50bd4cd792a9 35 fields · synced Jun 29, 2026