Arctic Sperm Cryopreservation Medium
Irvine Scientific Sales Co., Inc.
IRVINE SCIENTIFIC LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3036495174 | 3036495174 | IRVINE SCIENTIFIC LLC | 1 | N | 2026-01-01 | 1830 E Warner Ave Santa Ana CA US 92705 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 337932 | 1306319932 | K991421 | FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB) | MQL | 1999-07-02 |
| 337932 | 1515198216 | K991343 | PVP (POLYVINYLPYRROLIDONE) | MQL | 1999-07-14 |
| 337932 | 1776064713 | K991342 | PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION | MQL | 1999-07-08 |
| 337932 | 1826558368 | K991341 | ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION | MQL | 1999-07-08 |
| 337932 | 1381772080 | K983588 | SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM | MQL | 1999-04-26 |
| 337932 | 1324581274 | K983586 | HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI | MQL | 1999-02-18 |
| 337932 | 1121127476 | K983584 | HUMAN SERUM ALBUMIN (HSA) | MQL | 1999-02-08 |
| 337932 | 1817595723 | K250445 | Fast Warm - NX | MQL | 2025-09-12 |
| 337932 | 1945125055 | K241341 | cryo-GO Vitrification Device | MQK | 2024-09-26 |
| 337932 | 1410845635 | K233764 | SSS-NX (Serum Substitute Supplement-NX) | MQL | 2024-04-24 |
| 337932 | 1924643581 | K190152 | Vit Kit- Freeze NX and Vit Kit- Warm NX | MQL | 2019-06-21 |
| 337932 | 1377837652 | K171224 | Arctic Sperm Cryopreservation Medium | MQL | 2017-08-31 |
| 337932 | 1400001691 | K170681 | Continuous Single Culture -NX (CSCM-NX) | MQL | 2017-06-08 |
| 337932 | 1430230574 | K170602 | Continuous Single Culture-NX Complete (CSCM-NXC) | MQL | 2017-06-07 |
| 337932 | 2035653240 | K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit | MQL | 2016-05-04 |
| 337932 | 1436871710 | K121572 | CONTINUOUS SINGLE CULTURE COMPLETE | MQL | 2012-07-19 |
| 337932 | 1079583928 | K121128 | MULTIPURPOSE HANDLING MEDIUM | MQL | 2012-06-06 |
| 337932 | 1288663889 | K072609 | SINGLE STEP MEDIUM | MQL | 2008-02-12 |
| 337932 | 1177884281 | K022931 | HYALURONIDASE SOLUTION | MQL | 2002-11-04 |
| 337932 | 1616864863 | K011938 | OIL FOR EMBRYO CULTURE | MQL | 2001-07-18 |
| 337932 | 1107646995 | ||||
| 337932 | 1853399195 |
Product Codes Associated With Registrations#
PMN#
Continuous Single Culture -NX (CSCM-NX)
Irvine Scientific Sales Co., Inc.
Continuous Single Culture-NX Complete (CSCM-NXC)
Irvine Scientific Sales Co., Inc.
Vit Kit-Freeze Oocytes, Embryos And PN Zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos And PN Zygotes Vitrification Thaw Kit
Irvine Scientific
CONTINUOUS SINGLE CULTURE COMPLETE
IRVINE SCIENTIFIC SALES CO., INC.
MULTIPURPOSE HANDLING MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
VIT KIT - FREEZE AND THAW
IRVINE SCIENTIFIC SALES CO., INC.
SINGLE STEP MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
LYOPHILIZED MULTIBLAST MEDIUM KIT
IRVINE SCIENTIFIC SALES CO., INC.
LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT
IRVINE SCIENTIFIC SALES CO., INC.
WALLACE ARTIFICIAL INSEMINATION CATHETER
IRVINE SCIENTIFIC SALES CO., INC.
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
IRVINE SCIENTIFIC SALES CO., INC.
CRYOTIP
IRVINE SCIENTIFIC SALES CO., INC.
MULTIBLAST MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
EARLY CLEAVAGE MEDIUM (ECM)
IRVINE SCIENTIFIC SALES CO., INC.
PHENOL RED STOCK SOLUTION
IRVINE SCIENTIFIC SALES CO., INC.
HYALURONIDASE SOLUTION
IRVINE SCIENTIFIC SALES CO., INC.
EMBRYO BIOPSY MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
EMBRYO FREEZE MEDIUM, EMBRYO THAW MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
OIL FOR EMBRYO CULTURE
IRVINE SCIENTIFIC SALES CO., INC.
WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
IRVINE SCIENTIFIC SALES CO., INC.
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
IRVINE SCIENTIFIC SALES CO., INC.
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
IRVINE SCIENTIFIC SALES CO., INC.
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
TYRODE'S SOLUTION-ACIDIFIED
IRVINE SCIENTIFIC SALES CO., INC.
MODIFIED HAM'S F-10 BASAL MEDIUM, MODIFIED HAMS'S F-10 BASAL MEDIUM HEPES, MODIFIED HAM'S F-10 SUPPLEMENT (50X) IYOPHILI
IRVINE SCIENTIFIC SALES CO., INC.
PVP (POLYVINYLPYRROLIDONE)
IRVINE SCIENTIFIC SALES CO., INC.
BOVINE SERUM ALBUMIN (BSA)
IRVINE SCIENTIFIC SALES CO., INC.
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
IRVINE SCIENTIFIC SALES CO., INC.
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
IRVINE SCIENTIFIC SALES CO., INC.
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
IRVINE SCIENTIFIC SALES CO., INC.
FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
IRVINE SCIENTIFIC SALES CO., INC.
MODIFIED HAM'S F-10 WITH ALBUMIN
IRVINE SCIENTIFIC SALES CO., INC.
SPERM WASHING MEDIUM, MODIFIED SPERM WASHING MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
SYNTHETIC SERUM SUBSTITUTE (SSS)
IRVINE SCIENTIFIC SALES CO., INC.
BLASTOCYST MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
IRVINE SCIENTIFIC SALES CO., INC.
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM
IRVINE SCIENTIFIC SALES CO., INC.
HUMAN SERUM ALBUMIN (HSA)
IRVINE SCIENTIFIC SALES CO., INC.
ISOLATE
IRVINE SCIENTIFIC SALES CO., INC.
GUDID#
Fast Warm-NX with Gentamicin - Fast Warm-NX is a dual solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50mg/mL therapeutic grade Human Serum Albumin (HSA) and 20mg/mL Dextran. DSS is used at 20% (v/v) in Fast Warm-NX for a final concentration of 10mg/mL HSA and 4 mg/mL Dextran.Fast Warm-NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.
2026-01-09
Fast Warm-NX with Gentamicin - Fast Warm-NX is a dual buffered solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Fast Warm-NX for a final concentration of 10mg/mL HSA and 4mg/mL Dextran. Fast Warm-NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.
2026-01-09
Continuous Single Culture Complete (CSCM-C) with Gentamicin and HSA - Continuous Single Culture Complete (CSCM-C) is a novel solution optimized for use in an uninterrupted culture system without dish change or medium renewal. CSCM-C contains Human Serum Albumin (HSA) and the antibiotic Gentamicin Sulfate.
2025-06-02
Sperm Washing Medium with HSA - Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle.
2025-06-02
CHANG Medium D - CHANG Medium D with L-Glutamine. 500mL bottle.
2025-06-02
CHANG Medium D - CHANG Medium D with L-Glutamine. 100mL bottle.
2025-06-02
CHANG Medium C Frozen Supplement (14mL) - C106-14ML
2025-06-02
CHANG Medium B - CHANG Medium Basal. 90mL bottle.
2025-06-02
CHANG Amnio - CHANG Amnio with Gentamicin and L-Glutamine. 100mL bottle.
2025-06-02
CHANG Medium D with Gentamicin - CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
2025-06-02
CHANG Marrow - Bone Marrow Culture Medium with Gentamicin. 500mL bottle.
2025-06-02
CHANG Marrow - Bone Marrow Culture Medium with Gentamicin. 100mL bottle.
2025-06-02
CHANG Medium MF Mitogen-Free - CHANG Medium MF with Gentamicin. Mitogen Free Medium for Culture of Hemopoietic Cells. 100mL bottle.
2025-06-02
CHANG Medium BMC Bone Marrow Culture Medium - CHANG Medium BMC Bone Marrow Culture Medium. 500mL bottle.
2025-06-02
CHANG Medium BMC Bone Marrow Culture Medium - CHANG Medium BMC Bone Marrow Culture Medium. 100mL bottle.
2025-06-02
Thawing NX-TS (Thawing Solution Add-On Pack) - Thawing NX-TS (Thawing Solution Add-On Pack) 2x20mL. To be used with Vit-Kit Warm NX.
2025-06-02
Continuous Single Culture - NX Complete (CSCM-NXC) with Gentamicin and HSA - CSCM-NXC is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. CSCM-NXC contains human serum albumin (HSA) and the antibiotic Gentamicin Sulphate.
2025-06-02
Continuous Single Culture - NX Complete (CSCM-NXC) with Gentamicin and HSA - CSCM-NXC is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. CSCM-NXC contains human serum albumin (HSA) and the antibiotic Gentamicin Sulphate.
2025-06-02
Continuous Single Culture - NX (CSCM-NX) with Gentamicin - CSCM-NX is a single step culture medium optimized to be used in an uninterrupted culture system, without dish change or medium renewal. The medium contains the antibiotic Gentamicin Sulphate.
2025-06-02
Continuous Single Culture (CSCM) with Gentamicin - Continuous Single Culture (CSCM) medium optimized to be used in an uninterrupted culture system without dish change or medium renewal. The medium contains Gentamicin Sulfate.
2025-06-02
Washing Solution Add-On Pack - Washing Solution Add-On Pack. Contains 6x2mL Thawing Solution-TS to be used with Vit-Kit Thaw.
2025-06-02
Thawing Solution Add-On Pack - Thawing Solution Add-On Pack. Contains 5x2mL Thawing Solution-TS to be used with Vit-Kit Thaw.
2025-06-02
Modified HTF Medium with Gentamicin - Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
2025-06-02
Modified HTF Medium with Gentamicin - Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This mediumcontains the antibiotic Gentamicin Sulfate and requires protein supplement.
2025-06-02
Human Tubal Fluid (HTF) Medium with Gentamicin - HTF Medium is a synthetic, defined solution for use as a culture media through Day 3 of human embryo development as well as the processing of gametes. HTF is bicarbonate-based and is designed for use in a CO2 incubator. HTF contains the antibiotic Gentamicin Sulphate.
2025-06-02
Colcemid Solution - Colcemid Solution 10µg/mL in Hank’s Balanced Salts
2025-06-02
PBS 1X Dulbecco's Phosphate Buffered Saline Solution - PBS 1X Dulbecco's Phosphate Buffered Saline Solution. 500mL bottle.
2025-06-02
ISolate Stock Solution - 90% Density Gradient Sperm Separation Medium
2025-06-02
ISolate Ready to Use Density Gradient Medium - ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 1x100mL Upper Layer and 1x100mL Lower Layer.
2025-06-02
ISolate Ready to Use Density Gradient Medium - ISolate Ready to Use Density Gradient Medium at Two Concentrations. Contains 6x6mL Upper Layer and 6x6mL Lower Layer.
2025-06-02
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS - Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 8x2mL Vials Thawing Solution-TS (yellow cap), 5x2mL Vials Dilution Solution-DS (orange cap) and 5x2mL Vials Washing Solution-WS (red cap).
2025-06-02
Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS - Vitrification Thaw Kit (Vit Kit-Thaw) with Gentamicin and DSS. Includes 4x2mL Vials Thawing Solution-TS (yellow cap), 1x2mL Vial Dilution Solution-DS (orange cap) and 1x2mL Vial Washing Solution-WS (red cap).
2025-06-02
Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS - Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 9x1mL Vials Equilibration Solution - ES (white cap) and 9x1mL Vials Vitrification Solution - VS (blue cap).
2025-06-02
Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS - Vitrification Freeze Kit (Vit Kit-Freeze) with Gentamicin and DSS. Includes 2x1mL Vials Equilibration Solution - ES (white cap) and 2x1mL Vials Vitrification Solution - VS (blue cap)
2025-06-02
Vit Kit - Freeze NX with Gentamicin and DSS - Vit Kit - Freeze NX (Vitrification Kit for Freezing) with Gentamicin and DSS. Includes 3x1mL Equilibration NX-ES (white cap), 3x1mL Vitrification NX-VS (blue cap), 1x1mL Washing NX-WS (red cap)
2025-06-02
Vit Kit - Warm NX with Gentamicin and DSS - Vit Kit - Warm NX (Vitrification Kit for Warming) with Gentamicin and DSS. Includes 6x2mL Vials Thawing NX-TS (yellow cap), 2x1mL Vials Dilution NX-DS (orange cap) and 4x1mL Vials Washing NX-WS (red cap)
2025-06-02
Multipurpose Handling Medium - Complete (MHM-C) with Gentamicin and HSA - MHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate.
2025-06-02
Multipurpose Handling Medium - Complete (MHM-C) with Gentamicin and HSA - MHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate.
2025-06-02
Multipurpose Handling Medium - Complete (MHM-C) with Gentamicin and HSA - MHM-C is dual buffered solution (HEPES and MOPS). MHM-C contains human serum albumin (HSA) and the antibiotic Gentamicin Sulfate.
2025-06-02
Multipurpose Handling Medium (MHM) with Gentamicin - Multipurpose Handling Medium (MHM) with Gentamicin is dual buffered solution (HEPES and MOPS) that provides a safe and secure environment to maintain viability of gametes and embryos during manipulations under ambient conditions.
2025-06-02