GEMINI 10041566

GUDID 04260678680010

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.

STRATEC SE

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: 04260678680010
• NIH Device Record Key: d0e3f0af-92da-4488-9db1-f048fb8102e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMINI
• Version Model Number: Compact Microplate Processor
• Catalog Number: 10041566
• Company DUNS: 340361455
• Company Name: STRATEC SE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com
• Phone: +490708279160
• Email: Gemini@stratec.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Environmental condition: The instrument is made for indoor use.
• Special Storage Condition, Specify: Between 0 and 0 *Sunlight: No direct sunlight. May mislead optical sensors and affect performance.
• Special Storage Condition, Specify: Between 0 and 0 *Altitude: Altitude up to 2000 m (6561 ft.) above mean sea level. Storage: as required for air travel.
• Special Storage Condition, Specify: Between 0 and 0 *Dust: No excessive dust
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Transport temperature between 41 and 122 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Operating humidity 30 - 80 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage humidity 10 - 85 % non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Transport humidity 10 - 85 % non-condensing
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260678680010 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-15
• Device Publish Date: 2025-09-05