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illumigene Mycoplasma External Control Kit

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name
illumigene Mycoplasma External Control Kit FDA UDI
Generic Name
Mycoplasma pneumoniae nucleic acid IVD, control FDA UDI
Device Name
The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program. FDA UDI
Model / Reference
279940 FDA UDI
Description
The illumigene Mycoplasma External Control Kit contains Positive and Negative Control Reagents for use with the illumigene Mycoplasma test kit. External controls are used as part of a routine quality control program. External controls are used as part of a routine quality control program. FDA UDI

Identifiers

Catalog Number
279940 FDA UDI
Primary DI / UDI-DI
00840733101144 FDA UDI
FDA Product Code
OOI FDA UDI
OZX FDA UDI
GMDN Term
Mycoplasma pneumoniae nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3980 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

illumigene Mycoplasma External Control Kit by Meridian Bioscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meridian Bioscience, Inc.

Sources (1)

  • FDA UDI ed74a0b5-f96e-4e2a-aabe-834adb73f105 37 fields · synced Jun 1, 2026