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 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
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
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
cryo-GO Vitrification Device - Red (Pack of 10) - cryo-GO Vitrification Device - Red (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Yellow (Pack of 10) - cryo-GO Vitrification Device - Yellow (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Blue (Pack of 10) - cryo-GO Vitrification Device - Blue (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Green (Pack of 10) - cryo-GO Vitrification Device - Green (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Purple (Pack of 10) - cryo-GO Vitrification Device - Purple (Pack of 10). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Red (Pack of 50) - cryo-GO Vitrification Device - Red (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Yellow (Pack of 50) - cryo-GO Vitrification Device - Yellow (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Blue (Pack of 50) - cryo-GO Vitrification Device - Blue (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Green (Pack of 50) - cryo-GO Vitrification Device - Green (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
cryo-GO Vitrification Device - Purple (Pack of 50) - cryo-GO Vitrification Device - Purple (Pack of 50). A device composed of a body and a cap for use in ART procedures which includes oocytes and embryoscryopreservation by vitrification. The device is to be used with a vitrification and warming protocol.
2025-06-02
SSS-NX (Serum Substitute Supplement - NX) - SSS-NX is a protein supplement consisting of approximately 50mg/mL protein in saline solution.
2025-06-02
SSS-NX (Serum Substitute Supplement - NX) - SSS-NX is a protein supplement consisting of approximately 50mg/mL protein in saline solution.
2025-06-02
7% PVP Solution with HSA - Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
2025-06-02
10% PVP Solution with HSA - Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 10% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
2025-06-02
Arctic Sperm Cryopreservation Medium - Arctic Sperm Cryopreservation Medium is a dual buffered solution containing HEPES and MOPS that provides a secure environment to maintain physiological pH while handling sperm pre- and post-thaw.
2025-06-02
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin - 90129-20x5ML
2025-06-02
Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin - 90128-20x5ML
2025-06-02
Sperm Washing Medium with HSA - Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
2025-06-02
Human Serum Albumin (HSA)100mg/mL in Normal Saline - Human Serum Albumin (HSA)100mg/mL in Normal Saline. Not for Injection.
2025-06-02
Heavy Oil for Embryo Culture - Sterile white mineral oil. 100mL bottle.
2025-06-02
Heavy Oil for Embryo Culture - Sterile white mineral oil. 500mL bottle.
2025-06-02
Oil for Embryo Culture - Sterile light mineral oil. 100mL bottle.
2025-06-02
Oil for Embryo Culture - Sterile light mineral oil. 500mL bottle.
2025-06-02
Hyaluronidase Solution - 90101-5x1mL
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
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
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
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
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
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
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 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 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
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
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