FDA Registration
Active
🇺🇸 United States
SCIGENE
Reg #: 3008514604
·
FEI: 3008514604
·
Expires 2026
Products
3
Proprietary Names
10
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- SCIGENE
- Registration Number
- 3008514604
- FEI Number
- 3008514604
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3350 Scott Blvd.,, Bldg. 39-02
- City
- Santa Clara
- State
- CA
- ZIP
- 95054
- Country
- US
Owner / Operator
- Firm Name
- SciGene
- Operator Number
- 10032944
- Address
- 3350 Scott Blvd., Bldg. 39-02
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Terry A Gill
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2010-10-15 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2010-10-15 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2010-06-25 |
Proprietary Names
CytoBrite Slide Incubation System
CytoBrite Slide Oven
CytoBrite Duo Slide Incubation System
Hybex
CytoBrite PLUS Slide Incubation System
MicroFISH Hybridization Oven
Model 700 Microarray Oven
Model 777 Microarray Oven
Model 400 Hybridization Incubator
Little Dipper Processor, Model 650c
Establishment Types
Manufacture Medical Device