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Profile: Path-Tec is a leading provider of specimen management products and services. We help laboratories effectively collect and transport samples through effective product design, distribution, tracking and information technology.
FDA Registration Number: 3007871198
8 Products/Services (Click for related suppliers)
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• Blood Alcohol Kit (Excludes Hiv Testing) (FDA Code: OIC / 862.3040) An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. |
• General Specimen Collection & Transport Kits |
• Phlebotomy Blood Collection Kit (FDA Code: OFM / 870.2750) An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body. |
• Prostate Biopsy Collection and Transport Kits |
• Specimen Collection Device (FDA Code: LIO / 866.2900) A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms. |
• Specimen Collection Kits |
• Urine Cytology Kits (FDA Code: OKY / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following: |
• Urine Transport Kit (Excludes Hiv Testing) (FDA Code: OHZ / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing. |