Alethia™ Mycoplasma Direct External Control Kit

FDA UDI

Class II (US FDA UDI)

by Meridian Bioscience, Inc.

Identity

Trade Name: Alethia™ Mycoplasma Direct External Control Kit FDA UDI
Generic Name: Mycoplasma pneumoniae nucleic acid IVD, control FDA UDI
Device Name: The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors. FDA UDI
Model / Reference: 479890 FDA UDI
Description: The Alethia Mycoplasma Direct External Control Kit contains Positive Control Reagent for use with the Alethia Mycoplasma Direct test kit. The External Positive Control Reagent is used in conjunction with the Alethia Sample Preparation Apparatus II/Negative Control III reagent provided with the Alethia Mycoplasma Direct Kit as part of routine Quality Control Testing. External controls are used to aid the user in detection of unexpected conditions that may lead to test errors. FDA UDI

Identifiers

Catalog Number: 479890 FDA UDI
Primary DI / UDI-DI: 00840733102103 FDA UDI
510(k) Number: K160829 FDA UDI
FDA Product Code: OZX FDA UDI
OOI FDA UDI
GMDN Term: Mycoplasma pneumoniae nucleic acid IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3980 FDA UDI
862.2570 FDA UDI
Commercial Distribution: 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

Category: Mycoplasma pneumoniae nucleic acid IVD, control

Alethia™ 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:

Alethia™ Mycoplasma Direct — MERIDIAN BIOSCIENCE, INC.

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 a272f516-33a8-4771-a8b4-5ce36a8face2 37 fields · synced May 29, 2026