What is FDA product code OOI?

The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

Clinical Chemistry › Laboratory InstrumentsReal Time Nucleic Acid Amplification System

Illumigene Mycoplasma

Name: illumigene Mycoplasma
Brand: illumigene Mycoplasma

"The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in…

Registry build 21.09.26

“The illumigene Mycoplasma DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat and nasopharyngeal swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management.

15manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Jiangsu (4), Shandong (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OOI
Manufacturer	City	Province	Registered as	Device types
Zhejiang Orient Gene Biotech	Huzhou	Zhejiang	Contract manufacturer	86
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43
Bioteke Corporation (Wuxi) Co., Ltd.	Wuxi	Jiangsu	Manufacturer	21
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19
Xian Tianlong Science AND Technology Co., Ltd.	Xi’An	Shaanxi	Manufacturer	8
Hangzhou Bioer Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Sansure Biotech Inc.	Changsha	Hunan	Manufacturer	4

Showing 12 of 15. All 15 manufacturers in China registered for Real Time Nucleic Acid Amplification System

Record

Regulatory record for illumigene Mycoplasma
Listed by	Meridian Bioscience, Inc., United States
FDA product code	OOI
Device type	Real Time Nucleic Acid Amplification System
Device class	Class 2
Regulation	21 CFR 862.2570
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K123423
Record published	2016-09-23
Record revised	2020-06-29 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature 2 to 8 °C
Distribution end date	2019-01-31

Catalogue Numbers

Catalogue numbers for illumigene Mycoplasma
Catalogue number	Size	Status
280550		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GeneXpert Dx System	Cepheid	37
Alinity m	Abbott Molecular, Inc.	20
GeneXpert Infinity-80 System	Cepheid	13
Fluorescence Quantitative PCR Detection System	Anitoa Biotechnology(Hangzhou)Co., Ltd.	12
GeneXpert®	Cepheid	10
Certified Pre-Owned GeneXpert Dx System	Cepheid	10
Bioer GeneExplorer Thermal Cycler	Hangzhou Bioer Technology Co., Ltd.	7
m2000	Abbott Molecular, Inc.	5
GeneXpert Infinity-48s System	Cepheid	5
Panther Fusion®	Hologic, Inc.	4
Bioer LineGene 9600 Plus Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	4
Bioer QuantGene 9600 Fluorescent Quantitative Detection System	Hangzhou Bioer Technology Co., Ltd.	3

Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243922	2025-03-20
K222779	2023-01-26
K220480	2022-07-11

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2022-06-22	Class II	Device Design	When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instru	459 (394 US, 65 OUS)
2022-02-15	Class II	Component design/selection	The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.	452 units (398 US, 54 OUS)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.