IRVINE SCIENTIFIC LLC

FDA Device Registration & Listing · Santa Ana, CA, US · Registration 3036495174

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
3036495174
FEI Number
3036495174
Entity Name
IRVINE SCIENTIFIC LLC
City/State/Country
Santa Ana, CA, US
Establishment Address
1830 E Warner Ave, Santa Ana, CA 92705, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
IRVINE SCIENTIFIC LLC (Owner Number: 10092955)
Owner / Operator Contact Address
1830 E Warner Ave, Santa Ana, CA 92705, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

7% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA) 10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA) HTF Medium with Gentamicin; Modified HTF Medium HEPES with Gentamicin Arctic Sperm Cryopreservation Medium Continuous Single Culture Complete Heavy Oil for Embryo Culture; Oil for Embryo Culture Hyaluronidase Solution Multipurpose Handling Medium; Multipurpose Handling Medium Complete Freezing Medium Test Yolk Buffer (TYB) with Gentamicin; Refrigeration Medium Test Yolk Buffer (TYB) with Gentamicin Continuous Single Culture with Gentamicin Vit Kit - Freeze NX Vit Kit - Warm NX Fast Warm Continuous Single Culture®–NX Complete (CSCM–NXC) Chang Medium D (with gentamicin) Chang Medium B Chang Medium MF Chang Medium C Kit (lyophilized) Chang Medium BMC Chang Amnio Chang Marrow (with gentamicin) Chang Medium In Situ Chang Medium C Kit (Lyophilized with Gentamicin) Colcemid Solution Chang Medium D Chang Medium C Vit Kit Vitrification Freeze Kit; Vit Kit Vitrification Thaw Kit PBS 1X - Dulbecco's Phosphate Buffered Saline Solution ISolate Fast Warm - NX Chang Medium D; Chang Medium D (with gentamicin); Chang Medium In Situ; Chang Medium MF; Colcemid Solution Chang Amnio; Chang Marrow (with gentamicin); Chang Medium B; Chang Medium BMC Chang Medium C; Chang Medium C Kit (Lyophilized with Gentamicin); Chang Medium C Kit (lyophilized) cryo-GO Vitrification Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
KIT Media And Components, Synthetic Cell And Tissue Culture Hematology Class 1 864.2220 2025-03-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-11
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-03-10
MQL Media, Reproductive Obstetrics/Gynecology Class 2 884.6180 2025-12-08
KIQ Kit, Culture, Chromosome Hematology Class 1 864.2260 2025-03-11
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2025-03-10

Official Correspondent

Robert Lahaderne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IRVINE SCIENTIFIC LLC
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
K832690 Sigma Chemical Co. MINIMUM ESSENTIAL MED. EAGLE M0268 1983-09-12
K861867 Hazleton Research Products, Inc. MEM ALPHA EAGLE MEDIUM 1986-05-29
K821916 Dutchland Laboratories, Inc. IMPROVED MEM-RICHTER'S POWDER MODIF. 1982-07-27
K810767 Dutchland Laboratories, Inc. RPMI 1640 MEDIUM 1981-05-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036495174. Last updated year: 2026. Please use registration number 3036495174 when referencing this establishment in official correspondence.
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