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Mycoplasma genitalium macrolide resistance primers
FDA UDIClass I (US FDA UDI)
by Diagenode
Identity
- Trade Name
- Mycoplasma genitalium macrolide resistance primers FDA UDI
- Generic Name
- Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Oligonucleotides designed to detect the mutations associated to macrolide resistance on 23S RNA (A2058C, A2058G, A2058T, A2058C and A2059G) FDA UDI
Identifiers
- Catalog Number
- PRD-061107 FDA UDI
- Primary DI / UDI-DI
- 15430001412069 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)
Mycoplasma genitalium macrolide resistance primers by Diagenode — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT).
- Aptima® — Hologic, Inc. · Class II
- Aptima® — Hologic, Inc. · Class II
- Mycoplasma genitalium macrolide resistance probes — Diagenode · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Diagenode
Sources (1)
- FDA UDI 198426a7-0b90-4170-a6d0-629ff6cc0e93 34 fields · synced May 31, 2026