Identity
- Trade Name
- Aptima® FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
- Device Name
- The Aptima® Controls Kit is for use with the Aptima® Assays for the detection of C. trachomatis and/or N. gonorrhoeae. These quality control reagents are to be used according to the instructions in the package insert of the appropriate Aptima® Assay to establish run validity. FDA UDI
- Model / Reference
- APTIMA CONTROLS KIT, IVD FDA UDI
- Description
- The Aptima® Controls Kit is for use with the Aptima® Assays for the detection of C. trachomatis and/or N. gonorrhoeae. These quality control reagents are to be used according to the instructions in the package insert of the appropriate Aptima® Assay to establish run validity. FDA UDI
Identifiers
- Catalog Number
- 301110 FDA UDI
- Primary DI / UDI-DI
- 15420045506237 FDA UDI
- FDA Product Code
- LSL FDA UDIQEP FDA UDINSU FDA UDIMKZ FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI866.3393 FDA UDI862.2570 FDA UDI866.3120 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, control
Aptima® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI c83e962a-273b-4a3f-ac2e-ea0eb0328017 36 fields · synced May 31, 2026