illumigene Mycoplasma Direct External Control Kit

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: illumigene Mycoplasma Direct External Control Kit FDA UDI
Generic Name: Mycoplasma pneumoniae nucleic acid IVD, control FDA UDI
Device Name: The illumigene Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the illumigene Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the illumigene Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. FDA UDI
Model / Reference: 279890 FDA UDI
Description: The illumigene Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the illumigene Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the illumigene Sample Preparation Apparatus II/Negative Control III reagent provided with the illumigene Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used as part of a routine quality control program. FDA UDI

Identifiers

Catalog Number: 279890 FDA UDI
Primary DI / UDI-DI: 00840733101281 FDA UDI
510(k) Number: K160829 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

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

Cleared under the same submission

K160829 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Meridian Bioscience, Inc.

Sources (1)

FDA UDI 6974bef1-dfa9-4254-a7ab-1eed81eee59f 38 fields · synced Jun 8, 2026