| 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 |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com | |
| Phone | +490708279160 |
| Gemini@stratec.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04260678680010 [Primary] |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GEMINI 98873161 not registered Live/Pending |
Grant Prideco, Inc. 2024-11-26 |
![]() GEMINI 98656156 not registered Live/Pending |
Applied Medical Technology, Inc. 2024-07-18 |
![]() GEMINI 98585431 not registered Live/Pending |
Cooper Machinery Services LLC 2024-06-05 |
![]() GEMINI 98567891 not registered Live/Pending |
WONIK IPS CO., LTD. 2024-05-24 |
![]() GEMINI 98484508 not registered Live/Pending |
Ballyhoo Hospitality, LLC 2024-04-04 |
![]() GEMINI 98484468 not registered Live/Pending |
Ballyhoo Hospitality, LLC 2024-04-04 |
![]() GEMINI 98425860 not registered Live/Pending |
Sunseeker U.S. Inc. 2024-02-28 |
![]() GEMINI 98418146 not registered Live/Pending |
Google LLC 2024-02-23 |
![]() GEMINI 98202646 not registered Live/Pending |
Google LLC 2023-09-28 |
![]() GEMINI 98170099 not registered Live/Pending |
Gemini IP, LLC 2023-09-07 |
![]() GEMINI 97772796 not registered Live/Pending |
AMC Performance Textiles, LLC 2023-01-30 |
![]() GEMINI 97648185 not registered Live/Pending |
DIRECTV, LLC 2022-10-26 |