Gemini

The GEMINI is a compact microplate processor designed for the automation of diagnostic ELISA/EIA and autoimmune assays. The instrument is to be used in clinics, laboratories, universities…

Registry build 21.09.26

The GEMINI is a compact microplate processor designed for the automation of diagnostic ELISA/EIA and autoimmune assays. The instrument is to be used in clinics, laboratories, universities and hospitals containing diagnostic facilities as well as blood banks. The workplace for the instrument shall be a dedicated laboratory (area) for diagnostic purposes. The laboratories are not restricted to, but may include small working spaces (areas). The GEMINI consists of a platform that performs ELISA and similar structured assays, and PC software that performs several instrument tasks and provides a graphical user interface. The GEMINI has an interface that can accommodate with an internal PC. The PC has a data connection to an external laboratory information system (which is not included in the GEMINI). The GEMINI has a loading bay for samples and reagents, and positions for disposable tips. The GEMINI also has a transport system and fixed positions for loading microplates. Loading of any of these items into the GEMINI instrument is to be performed by the operator. Sample and reagent vessels come with attached barcodes that encode the identifier of the corresponding sample or reagent. The GEMINI reads the barcodes and stores the identifier. Barcodes on microplates cannot automatically be scanned by the instrument. The device must be validated in the specific application according to laboratory practice and state-of-the-art before putting into service and after changes. Use of kits or kit components on the GEMINI instrument is only allowed after validation. Using/running hazardous substances on the GEMINI instrument is in the responsibility of the operator.

16manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (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 JJE
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Zhejiang Orient Gene Biotech Huzhou Zhejiang Contract manufacturer 86
Biobase Biodustry(Shandong)Co., Ltd. Jinan Shandong Manufacturer 70
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
Shenzhen Yhlo Biotech Co., Ltd. Shenzhen Guangdong Manufacturer 19
Getein Biotech, Inc. Nanjing Jiangsu Manufacturer 19
Beijing Hotgen Biotech Co., Ltd. Beijing Beijing Manufacturer 13
Yantai Addcare Bio-Tech Co., Ltd. Yantai Shandong Contract manufacturer 8
Shenzhen NEW Industries Biomedical Engineering Co., Ltd. Shenzhen Guangdong Manufacturer 4
Shanghai Kehua Laboratory System Co., Ltd. Shanghai Shanghai Manufacturer 4

Showing 12 of 16. All 16 manufacturers in China registered for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Record

Regulatory record for Gemini
Listed by Stratec SE, Germany
FDA product code JJE
Device type Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class Class 1
Regulation 21 CFR 862.2160
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2025-09-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Special storage condition: Environmental condition: The instrument is made for indoor use.; Special storage condition: Sunlight: No direct sunlight. May mislead optical sensors and affect performance.; Special storage condition: Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.; Special storage condition: Dust: No excessive dust; Storage environment temperature 41 to 122 °F; Special storage condition: Transport temperature between 41 and 122 Degrees Fahrenheit

Catalogue Numbers

Catalogue numbers for Gemini
Catalogue number Size Status
Compact Microplate Processor In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alinity Abbott Medical 283
Architect Abbott Laboratories 115
Alinity Abbott Laboratories 18
Biobase Biobase Biodustry(Shandong)Co., Ltd. 15
Vitros Ortho-Clinical Diagnostics, Inc. 14
Architect Abbott Ireland Diagnostics 8
AU Beckman Coulter, Inc. 7
Alinity Abbott Ireland Diagnostics 6
DxC AU Beckman Coulter, Inc. 6
Chemiluminescence Immunoassay Analyzer Shenzhen Yhlo Biotech Co., Ltd. 6
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 Tosoh Corp. 5
Pictus 500 Clinical chemistry analyzer Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag 4

Showing 12 of 336. All products under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer