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Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic material for the purpose or pre-implantation genetic diagnosis. These devices are intended for single use and will be supplied sterile. The labeling will contain the following statement, in prominent and boxed format: "This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by individual laboratories for their own use. The enafactoriance of these tests may vary depending on the particular assay and disease performance of ammy these tests have not been cleared or approved by the Food and Drug Administration."

Biopsy Micropipets are used to remove polar bodies from the zygote (polar body) or blastomeres from the embryo (blastomere biopsy) for the purpose of preimplantation genetic diagnosis. These devices are manufactured from borosilicate glass on which 2 cell mouse embryo and endotoxin testing are performed. They are manufactured following procedures of the Humagen Quality System. The pipets are manufactured to specific sizes or the size may be modified to meet customer specifications.

The micropipet family's intended use is to manipulate zygotes during the ICSI procedure. The micropipets are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation. The micropipets are tools used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male fertility is impaired.

Micropipets are fabricated from 1 mm. diameter borosilicate glass capillary tubes. One end of the glass tube is pulled to a much smaller diameter using a glass puller with a heated coil. Diameters range from 2 - 3 um to 200 um depending upon the type of micropipet. Most micropipets are ground on a microgrinder to produce a beveled or flat opening. Generally, a sharp spike is pulled on beveled micropipets by touching the bevel to a heated glass bead and withdrawing quickly. Angles may be added along the shaft of the micropipet per request of the end user to best fit their micromanipulation equipment. Specifications for each variation of micropipet is as follows: Intracytoplasmic Sperm Injection Micropipets (ICSI) - pulled to a 6 to 7 um outer diameter, 4 to 5 um inner diameter with a 35 or 50 degree bevel and a short, sharp point or may be made with no point. May be straight or with an angle (15 - 45 degrees as specified), 0.5mm from the beveled end. Any of these parameters may be modified to meet customer specifications. Spermatid ICSI Micropipets - pulled to a 9 um outer diameter, 7 to 8 um inner diameter with a 35 or 50 degree bevel and a short, sharp point at the tip. May be straight or with an angle (15 to 45 degrees as specified), 0.5 mm from the beveled end. Again, parameters may vary somewhat depending on customer specifications. Holding Micropipets - one end is pulled to the specified outer diameter, which can range from 65 um to 180 um, scored and cut to yield a blunt opening of the appropriate size, and polished over a hot glass bead to a 20 to 25 um inner diameter opening, unless otherwise specified. Small holding micropipets are pulled to an outer diameter of 65 to 95 um, medium holdings are pulled to an outer diameter of 100 to 120 um, large holdings are pulled to an outer diameter of 125 to 150 um, and extra large holding micropipets are pulled to an outer diameter of 155 to 180 um. Holding micropipets may be angled or straight. Assisted Hatching Micropipets - one end is pulled to a standard outer diameter of 8 to 10 um unless otherwise specified, with a blunt opening. Other outer diameter sizes are available upon request. Assisted hatching micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end. Subzonal Insertion Micropipets (SUZI) - one end is pulled to a 10 to 12 um outer diameter with a 40 degree bevel, and a short, sharp point at the tip. SUZI micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end. Partial Zona Dissection Micropipets (PZD) - one end is pulled to a long, thin taper with a closed, sharp point. PZD micropipets may be straight or angled (15 to 45 degrees as specified), 0.5 mm from the tapered end. Denuding Micropipets - one end is pulled and then cut with a diamond knife to an opening of 150 or 190 um inner diameter with a blunt opening.

The NewLife Dish's intended use is to hold zygotes/embryos during micromanipulation or other tissue culture procedures in the IVF laboratory. NewLife Dishes are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to reimplantation. The dishes are disposable tissue culture labware used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male infertility is impaired.

NewLife Dishes are fabricated from polysterene and are 60 mm. diameter. Dishes are made with or without clear lids, etched or unetched. Etched dishes have a center circle with 8 smaller circles inside the larger circle, and a 9th circle inside the 8 circles. There are numbers 1 through 8 outside the large circle, with the number 1 at the top of the dish. Unetched dishes have center circles, but no other circles are etched on the dishes. Dishes are disposable, intended for one time use only.