FDA.reportPublic FDA data

IRVINE SCIENTIFIC LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30364951743036495174IRVINE SCIENTIFIC LLC1N2026-01-011830 E Warner Ave Santa Ana CA US 92705

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3379321306319932K991421FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)MQL1999-07-02
3379321515198216K991343PVP (POLYVINYLPYRROLIDONE)MQL1999-07-14
3379321776064713K991342PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTIONMQL1999-07-08
3379321826558368K991341ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTIONMQL1999-07-08
3379321381772080K983588SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUMMQL1999-04-26
3379321324581274K983586HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITIMQL1999-02-18
3379321121127476K983584HUMAN SERUM ALBUMIN (HSA)MQL1999-02-08
3379321817595723K250445Fast Warm - NXMQL2025-09-12
3379321945125055K241341cryo-GO Vitrification DeviceMQK2024-09-26
3379321410845635K233764SSS-NX (Serum Substitute Supplement-NX)MQL2024-04-24
3379321924643581K190152Vit Kit- Freeze NX and Vit Kit- Warm NXMQL2019-06-21
3379321377837652K171224Arctic Sperm Cryopreservation MediumMQL2017-08-31
3379321400001691K170681Continuous Single Culture -NX (CSCM-NX)MQL2017-06-08
3379321430230574K170602Continuous Single Culture-NX Complete (CSCM-NXC)MQL2017-06-07
3379322035653240K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw KitMQL2016-05-04
3379321436871710K121572CONTINUOUS SINGLE CULTURE COMPLETEMQL2012-07-19
3379321079583928K121128MULTIPURPOSE HANDLING MEDIUMMQL2012-06-06
3379321288663889K072609SINGLE STEP MEDIUMMQL2008-02-12
3379321177884281K022931HYALURONIDASE SOLUTIONMQL2002-11-04
3379321616864863K011938OIL FOR EMBRYO CULTUREMQL2001-07-18
3379321107646995
3379321853399195

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQL192025-09-12
MQK12024-09-26