Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator FDA UDI
- Device Name
- Aptima® HPV Assay Calibrators Kit. FDA UDI
- Model / Reference
- KIT,HPV,APTIMA, CALIBRATORS, IVD FDA UDI
- Description
- Aptima® HPV Assay Calibrators Kit. FDA UDI
Identifiers
- Catalog Number
- 303010 FDA UDI
- Primary DI / UDI-DI
- 15420045500075 FDA UDI
- PMA Number
- P100042 FDA UDI
- FDA Product Code
- OYB FDA UDI
- GMDN Term
- Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibrator 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, calibrator
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, calibrator.
- Aptima® — Hologic, 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 a00e22cb-167f-4adf-88c4-3304706b4495 37 fields · synced May 30, 2026