Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® CT assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Chlamydia trachomatis assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified. FDA UDI
- Model / Reference
- KIT, BX 1 (REF) ACT, 100T, AS, IVD FDA UDI
- Description
- Aptima® CT assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Chlamydia trachomatis assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) to aid in the diagnosis of chlamydial urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified. FDA UDI
Identifiers
- Catalog Number
- 302933 FDA UDI
- Primary DI / UDI-DI
- 15420045505407 FDA UDI
- FDA Product Code
- MKZ FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3120 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class I — 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).
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- 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
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 47e6feda-79bc-413c-8faa-aa141bfb4600 36 fields · synced Jun 8, 2026