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Mycoplasma genitalium macrolide resistance probes

FDA UDI

Class I (US FDA UDI)

by Diagenode

Identity

Trade Name
Mycoplasma genitalium macrolide resistance probes FDA UDI
Generic Name
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label FDA UDI
Model / Reference
1 FDA UDI
Description
Oligunucleotides designed to detect mutations associated to macrolide resistance on 23S RNA (A2058C, 2058G, 2058T, 2059C, A2059G). These oligonucleotides contain a 5' FAM label and a 3' BHQ-1 label FDA UDI

Identifiers

Primary DI / UDI-DI
15430001412076 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 probes 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).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagenode

Sources (1)

  • FDA UDI 73c40cd5-75d0-43bb-902c-1ab53b32f741 33 fields · synced Jun 6, 2026