GEMINI

Basic Information

• Brand Name: GEMINI
• Primary DI: 04260678680010
• Version / Model: Compact Microplate Processor
• Catalog Number: 10041566
• Company Name: STRATEC SE
• Labeler DUNS: 340361455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-05
• Public Version: 1
• Public Version Date: 2025-09-15
• Public Version Status: New
• Public Device Record Key: d0e3f0af-92da-4488-9db1-f048fb8102e6

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56718	Enzyme immunoassay (EIA) analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260678680010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Environmental condition: The instrument is made for indoor use.
• Type: Special Storage Condition, Specify
• Special Conditions: Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Type: Special Storage Condition, Specify
• Special Conditions: Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Type: Special Storage Condition, Specify
• Special Conditions: Dust: No excessive dust
• Type: Storage Environment Temperature
• Temperature Range: 41 – 122 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Transport temperature between 41 and 122 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Operating humidity 30 - 80 % non-condensing
• Type: Special Storage Condition, Specify
• Special Conditions: Storage humidity 10 - 85 % non-condensing
• Type: Special Storage Condition, Specify
• Special Conditions: Transport humidity 10 - 85 % non-condensing
• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit