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Mycoplama genitalium IVT Wild type control

FDA UDI

Class I (US FDA UDI)

by Diagenode

Identity

Trade Name
Mycoplama genitalium IVT Wild type control FDA UDI
Generic Name
Mycoplasma genitalium nucleic acid IVD, control FDA UDI
Device Name
In vitro transcript of Mycoplasma genitalium 23S RNA FDA UDI
Model / Reference
1 FDA UDI
Description
In vitro transcript of Mycoplasma genitalium 23S RNA FDA UDI

Identifiers

Primary DI / UDI-DI
15430001412137 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Mycoplasma genitalium nucleic acid IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mycoplasma genitalium nucleic acid IVD, control

Mycoplama genitalium IVT Wild type control by Diagenode — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mycoplasma genitalium nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagenode

Sources (1)

  • FDA UDI 0afbce89-4005-44cb-863a-a7b77969ad55 33 fields · synced May 29, 2026