gudid
Primary ID: Compact Microplate Processor
GEMINI (UDI Compact Microplate Processor)
Manufactured by STRATEC SE
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for GEMINI - Primary ID Compact Microplate Processor
Device Regulatory Overview
The GEMINI (Model/Catalog Number: Compact Microplate Processor) is a medical device manufactured by STRATEC SE. This product is indexed under FDA Product Code / Category Classification JJE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Compact Microplate Processor
- Product Code / EMDN
- JJE
- Device Name
- 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 microplatescannot 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.
- Database Sync Date
- 2026-08-09 09:53:17
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of GEMINI?
The registered manufacturer of record for GEMINI is STRATEC SE.
What is the Primary UDI-DI identifier for GEMINI?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Compact Microplate Processor.
What classification code is assigned to this device?
This device is registered under product classification code JJE.
Similar Classification Devices (JJE)
Other Devices by STRATEC SE
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