FUJIFILM Biosciences INC.

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 2022379

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
2022379
FEI Number
2022379
Entity Name
FUJIFILM Biosciences INC.
City/State/Country
Santa Ana, CA, US
Establishment Address
2511 DAIMLER ST, Santa Ana, CA 92705, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
FUJIFILM Holdings America Corporation (Owner Number: 2022379)
Owner / Operator Contact Address
2511 DAIMLER STREET, --, Santa Ana, CA 92705, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Hyaluronidase Solution Continuous Single Culture with Gentamicin Fast Warm NX cryo-GO Human Serum Albumin (HSA) Refrigeration Medium Test Yolk Buffer (TYB) with Gentamicin Freezing Medium Test Yolk Buffer (TYB) with Gentamicin Continuous Single Culture®–NX (CSCM–NX) SSS-NX (Serum Substitute Supplement-NX) ISolate® Stock Solution ISolate® Modified HTF Medium HEPES with Gentamicin HTF Medium with Gentamicin Arctic Sperm Cryopreservation Medium PBS 1X - Dulbecco's Phosphate Buffered Saline Solution Vit Kit - Freeze NX Vit Kit - Warm NX Chang Medium C; Chang Medium C Kit (Lyophilized with Gentamicin); Chang Medium C Kit (lyophilized) Chang Amnio; Chang Marrow (with gentamicin); Chang Medium B; Chang Medium BMC Chang Medium D; Chang Medium D (with gentamicin); Chang Medium In Situ; Chang Medium MF; Colcemid Solution Multipurpose Handling Medium Multipurpose Handling Medium Complete Continuous Single Culture Complete

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-13
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-12-17
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2024-10-16
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2017-07-25
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2024-05-21
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2017-09-07
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2014-06-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2019-07-02
KIQ Kit, Culture, Chromosome Hematology Class 1 864.2260 1992-12-14
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2013-12-03
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2013-12-03

Official Correspondent

Marlin Frechette

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUJIFILM Holdings America Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K011481 Conception Technologies 10% PVP; 10% PVP IN EBSS SOLUTION 2001-07-02

Similar Registrations

Registration Number Establishment Name Location
2031824 Vitrolife Inc. San Diego, CA, US
3014295858 COOPER MEDICAL, SRL La Garita Alajuela, CR
3014755376 CooperSurgical Distribution B.V. Herten Limburg, NL
3036725842 GYNOTEC B.V. Malden Gelderland, NL
3004048494 ORIGIO A/S Ballerup Hovedstaden, DK
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2022379. Last updated year: 2026. Please use registration number 2022379 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.