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The HemoChek Sample Collection Kit is indicated for use in the measurement of HbA1c on blood specimens which can be collected at the patient's home or at a physician's office on a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.

The HemoChek Sample Collection Kit is a kit which is sent to the patient's home after the patient has been enrolled in the HemoChek program by the patient's physician. The kit consists of the following: - A Sample Card containing the proprietary filter paper that the blood sample is deposited on. the patient's name and address, instructions on how to obtain the sample and send it to Osborn Laboratories and a place to make changes to any of the patient's information. - A pamphlet containing a description of the HemoChek program and detailed instructions about how to obtain a blood sample and mail it to Osborn Laboratories. - A self-adhesive envelope in which the card is inserted and then mailed to the preprinted address on the envelope. - The mailing envelope which is used to mail the above three items to the patient. After receiving the HemoChek Sample Collection Kit in the mail from Osborn Laboratories, the patient then collects a blood sample, using a lancet. The blood sample is placed on all three circles on the right hand side of the sample collection card, as described in the instructions. Then the card is placed in the mailing envelope provided in the kit and mailed to Osborn Laboratories. When the blood sample is received by Osborn Laboratories the patient's HbA1c level is measured using existing assay methods.

The Oral-Eze Oral Fluid Collection System is a prescription device, intended for use by a person under the supervision of a trained health care professional to collect oral fluid specimens, contain these specimens, and preserve the specimens after collection and during transport from the collection area to the laboratory.

The Oral-Eze Oral Fluid Collection System is a device used by a person under the supervision of a trained health care professional to obtain an oral fluid specimen and have the specimen contained for transport to a laboratory. The device consists of the following: - A collector pad holder/handle with a collector pad, contained in a sealed "peel-apart" plastic envelope. . The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a predetermined amount of oral fluid has been collected. - An Oral Fluid Collection Tube with a screw-on lid, containing preservative fluid. .. - A clear plastic sealed envelope that contains all three of the above items. .