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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2025-03-10 |
| Media And Components, Synthetic Cell And Tissue Culture | KIT | Class 1 | Hematology | No | 2025-03-11 |
| Kit, Culture, Chromosome | KIQ | Class 1 | Hematology | No | 2025-03-11 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2025-03-10 |
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 (CSCMNXC)
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 (CSCMNX)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device