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

BD Pre-Warm Heater

Name: BD Pre-Warm Heater
Brand: BD Pre-Warm Heater

2 catalogue numbers from 442950, listed by Becton, Dickinson AND Company, 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

2catalogue numbers in this listing

1510(k) clearance

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 BD Pre-Warm Heater
Listed by	Becton, Dickinson AND Company, 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, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K140447
Record published	2016-05-19
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, serial number
Storage	Storage environment temperature 18 to 33 °C
Sizes	Depth 54.4 cm; width 29.7 cm; height 13 cm

Catalogue Numbers

Catalogue numbers for BD Pre-Warm Heater
Catalogue number	Size	Status
442950	Depth 54.4 cm	In distribution
443159		In distribution

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
K140447	2014-05-20

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of BD Pre-Warm Heater
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Becton, Dickinson & Co.	510(k) number	2015-12-14	Class II	Software design	BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the	2	2017-04-19
Becton, Dickinson & Co.	510(k) number	2014-11-07	Class II	Device Design	Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.	7 Viper LT Systems	2016-05-09

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.