INVITROCARE, INCORPORATED

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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

Product Code : MQL

Prescription Use : No

Device Count : 1

Device Description : SPERM FREEZING MEDIUM - SpermFreeze is a HEPES buffered freezing medium for use SPERM FREEZING MEDIUM - SpermFreeze is a HEPES buffered freezing medium for use with human sperm. It contains 0.4% human serum albumin. SPERM FREEZING MEDIUM - SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1

- Catalog Number : 2002-L

Device Description : HTF HEPES is a synthetic, defined culture medium intended for use in assisted re HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn metal (Quinn P, Kerin JF, Warnes GM:Fertil Steril 1985;44:493-498). HTF HEPES uses 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.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1

- Catalog Number : 2005-L

Device Description : SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/m SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses 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.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1

- Catalog Number : 2212-10

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

Product Code : MQL

Prescription Use : No

Device Count : 1

Device Description : SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/m SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses 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.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1

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

Product Code : MQL

Prescription Use : No

Device Count : 1

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. SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses 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.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1

Device Description : SPERM WASH MEDIUM for Swim-Up is a synthetic, defined culture medium supplemente SPERM WASH MEDIUM for Swim-Up is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM for Swim-Up uses 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.

Device Class : 2

Duns Number: 190094230

Premarket Exempt : No

Product Code : MQL

Prescription Use : No

Device Count : 1