Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima® HPV Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
- Model / Reference
- KIT, BX 2 (RT) HPV,100-T,AS, US IVD FDA UDI
- Description
- Aptima® HPV Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
Identifiers
- Catalog Number
- 303572 FDA UDI
- Primary DI / UDI-DI
- 15420045500105 FDA UDI
- PMA Number
- P100042 FDA UDI
- FDA Product Code
- OYB FDA UDI
- GMDN Term
- Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class III 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: Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT).
- cobas® 4800 System Wash Buffer Kit — Roche Molecular Systems, Inc. · Class III
- cobas HPV for use on the cobas 6800/8800 systems — Roche Molecular Systems, Inc. · Class III
- cobas® 4800 HPV Amplification/Detection Kit — Roche Molecular Systems, Inc. · Class III
- cobas®4800 System Liquid Cytology Preparation Kit — Roche Molecular Systems, Inc. · Class III
- cobas® 4800 HPV Amplification/Detection Kit — Roche Molecular Systems, Inc. · Class III
- cobas® 4800 System Sample Preparation Kit — Roche Molecular Systems, Inc. · Class III
- Alinity m — Abbott Molecular · Class III
- cobas HPV — Roche Molecular Systems, Inc. · Class III
Cleared under the same submission
P100042 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 III | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 121c3362-bb66-4bdc-90d1-173ee88779b8 37 fields · synced Jun 1, 2026