Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
- Model / Reference
- BOX 2 ROOM TEMP, SARS-COV-2 ASSAY, APTIMA 100T IVD FDA UDI
- Description
- Aptima® SARS-CoV-2 Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
Identifiers
- Catalog Number
- ASY-17190 FDA UDI
- Primary DI / UDI-DI
- 15420045517004 FDA UDI
- 510(k) Number
- K243396 FDA UDI
- FDA Product Code
- QQX FDA UDI
- GMDN Term
- SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3981 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: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT).
- RealTime — Abbott Molecular · N
- ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) — VELA OPERATIONS SINGAPORE PTE. LTD.
- cobas liat SARS-CoV-2 v2 nucleic acid test — Roche Molecular Systems, Inc. · Class II
- Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit — LIFE TECHNOLOGIES LIMITED · Class II
- Simplexa COVID-19 Positive Control GEN II Pack — DiaSorin Molecular LLC · Class II
- Accula SARS-CoV-2 Test — MESA BIOTECH, INC. · N
- Lyra — DIAGNOSTIC HYBRIDS, INC. · N
- EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AG · N
Cleared under the same submission
K243396 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 7b65757d-4d75-4f15-9992-297b7e317f17 37 fields · synced Jun 1, 2026