SCIGENE

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3008514604

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008514604
FEI Number
3008514604
Entity Name
SCIGENE
City/State/Country
Santa Clara, CA, US
Establishment Address
3350 Scott Blvd.,, Bldg. 39-02, Santa Clara, CA 95054, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SciGene (Owner Number: 10032944)
Owner / Operator Contact Address
3350 Scott Blvd., Bldg. 39-02, Santa Clara, CA 95054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JRG Block, Heating Clinical Chemistry Class 1 862.2050 2010-10-15
JTQ Bath, Incubators/Water, All Microbiology Class 1 866.2540 2010-10-15

Official Correspondent

Terry Gill

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SciGene
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3033848228 JOAN LAB EQUIPMENT (ZHEJIANG) CO.,LTD. Huzhou Zhejiang, CN
3005174594 NANO-DITECH CORPORATION Cranbury, NJ, US
1319130 Crosstex International Rush, NY, US
8043629 SCICAN LTD. TORONTO Ontario, CA
1528450 Ortho-Clinical Diagnostics, Inc. ATHENS, OH, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008514604. Last updated year: 2026. Please use registration number 3008514604 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.