FDA Registration Active 🇺🇸 United States

IRVINE SCIENTIFIC LLC

Reg #: 3036495174 · FEI: 3036495174 · Expires 2026
Products
4
Proprietary Names
30
Establishment Types
3
Classifications
4

Registration Details

Registration Name
IRVINE SCIENTIFIC LLC
Registration Number
3036495174
FEI Number
3036495174
Status
Active
Expiry Year
2026
Initial Importer
No
Address
1830 E Warner Ave
City
Santa Ana
State
CA
ZIP
92705
Country
US

Regulatory Submissions

510(k) Number
K991343

Owner / Operator

Firm Name
IRVINE SCIENTIFIC LLC
Operator Number
10092955
Address
1830 E Warner Ave
City
Santa Ana
State
CA
Postal Code
92705
Country
US
Correspondent
Robert Lahaderne

Products

Device Name Product Code
Media, Reproductive MQL
Media And Components, Synthetic Cell And Tissue Culture KIT
Kit, Culture, Chromosome KIQ
Labware, Assisted Reproduction MQK

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 Sperm Washing Medium Human Serum Albumin (HSA) SSS-NX (Serum Substitute Supplement-NX) Continuous Single Culture®–NX (CSCM–NX)

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device