Identity
- Trade Name
- Aptima Mycoplasma genitalium Assay EUDAMEDAptima® FDA UDI
- Generic Name
- Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Aptima Mycoplasma genitalium Assay EUDAMEDAptima® Mycoplasma genitalium Assay, 100 test, box 1 of 2 (2°C to 8°C box). FDA UDI
- Model / Reference
- PRD-03374 EUDAMEDKIT, BX 1 (REF) M GEN, 100T, AS, IVD FDA UDI
- Description
- Aptima® Mycoplasma genitalium Assay, 100 test, box 1 of 2 (2°C to 8°C box). FDA UDI
Identifiers
- Catalog Number
- ASY-09407 FDA UDI
- Primary DI / UDI-DI
- 15420045509146 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455DIAGAPTMGENY9 EUDAMED
- Direct Marketing DI
- 15420045509146 EUDAMED
- FDA Product Code
- QEP FDA UDI
- EMDN Code
- W010501080302 UROGENITAL MYCOPLASMA DETECTION BY NA REAGENTS EUDAMED
- GMDN Term
- Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)
Aptima® by Hologic, Inc. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT).
- Mycoplasma genitalium macrolide resistance primers — Diagenode · Class I
- Mycoplasma genitalium macrolide resistance probes — Diagenode · Class I
- Aptima® — Hologic, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 1e1f732e-b376-474c-bb20-0e691904a5e8 36 fields · synced Jun 18, 2026
- EUDAMED 4979e54e-7566-4142-99f3-1b81755e03dc 61 fields · synced Jun 18, 2026