Device Description : HUMAN SERUM ALBUMIN consists of human serum albumin from therapeutic-grade sourc HUMAN SERUM ALBUMIN consists of human serum albumin from therapeutic-grade source material at a concentration of 100mg/ml in a sterile saline solution. HUMAN SERUM ALBUMIN is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth and embryo cryopreservation.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : InVitroCare's Polyvinylpyrrolidone (PVP) reagent is composed of polyvinylpyrroli InVitroCare's Polyvinylpyrrolidone (PVP) reagent is composed of polyvinylpyrrolidone (MW:360,000) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. PVP is intended for use as a medium for the immobilization and isolation of single sperm cells during intracytoplasmic sperm injection (ICSI) procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase ( InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL MINERAL OIL - Oil for Tissue Culture is a colorless liquid paraffin. MINERAL OIL - Oil for Tissue Culture is used in covering tissue culture in in vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : SPERMCARE 100% - Gradient System is a 100% solution of silane-coated silica part SPERMCARE 100% - Gradient System is a 100% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE 100% - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silic SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silic SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silic SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No
Device Description : SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silic SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
Device Class : 2
Duns Number: 190094230
Premarket Exempt : No
Prescription Use : No