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Aptima Mycoplasma genitalium Assay Calibrators Kit
EUDAMEDFDA UDIFDA 510(k)Class C (EU MDR)
Ref PRD-03393
by Hologic
Identity
- Trade Name
- Aptima Mycoplasma genitalium Assay Calibrators Kit EUDAMEDAptima® FDA UDI
- Generic Name
- Mycoplasma genitalium nucleic acid IVD, calibrator FDA UDI
- Device Name
- Aptima Mycoplasma genitalium Assay EUDAMEDAptima® Mycoplasma genitalium Assay Calibrators Kit. FDA UDI
- Model / Reference
- PRD-03393 EUDAMEDKIT, M GEN, CALIBRATOR 100T, AS, IVD FDA UDI
- Description
- Aptima® Mycoplasma genitalium Assay Calibrators Kit. FDA UDI
Identifiers
- Catalog Number
- PRD-03393 FDA UDI
- Primary DI / UDI-DI
- 15420045509160 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTMGENY9 EUDAMED
- Unit of Use DI
- 05420045509163 EUDAMED
- FDA Product Code
- QEP FDA UDI
- EMDN Code
- W0105080901 BACTERIOLOGY STANDARDS AND CALIBRATORS - INF.IMM. EUDAMED
- GMDN Term
- Mycoplasma genitalium nucleic acid IVD, calibrator FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.3393 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Aptima Mycoplasma genitalium Assay Calibrators Kit by Hologic Inc. — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | DEN180047 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 54200455DIAGAPTMGENY9 | Class C | Active |
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Manufacturer
- Manufacturer
- Hologic
- EUDAMED SRN
- US-MF-000001646
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (3)
- EUDAMED d68961e2-0aa1-4a83-801d-69e386f116c8 61 fields · synced Jun 20, 2026
- FDA UDI e5a5a1cb-7392-46e9-90bc-83b476efe10a 36 fields · synced May 25, 2026
- FDA 510(k) DEN180047 1 fields · synced Jun 4, 2026