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

Cobas Liat Influenza AB Script Version 1.33

Name: cobas Liat Influenza AB Script Version 1.33
Brand: cobas Liat Influenza AB Script Version 1.33

Catalogue number 08403864001, listed by Roche Molecular Systems, Inc., United States, under Real Time Nucleic Acid Amplification System. 15 manufacturers in China are registered for this product code.

Registry build 21.09.26

15manufacturers in China registered for this device type

1catalogue number

4recalls 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 cobas Liat Influenza AB Script Version 1.33
Listed by	Roche Molecular Systems, 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	Specification developer, Manufacturer, Exporter
Record published	2017-11-17
Record revised	2022-03-22 (version 4)

Specifications

Specifications
MRI safety	MR Safe
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2019-11-12

Catalogue Numbers

Catalogue numbers for cobas Liat Influenza AB Script Version 1.33
Catalogue number	Size	Status
08403864001		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

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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	Closed
2021-11-16	Class II	Nonconforming Material/Component	Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of fals	14 units
2014-01-06	Class II	Device Design	Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from different lots of the cobas PCR Urine kits, cobas PCR Female Swab kits, and cobas PCR media kits.	84 kit batches	2014-08-07
2013-04-01	Class II	Software design	In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the cobas 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report	425 instruments	2014-08-07
2012-02-24	Class III	Nonconforming Material/Component	During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the	264 kits to 13 EU countries; 2 kits to Canada and 33 kits to	2013-07-16

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.