AMERICAN BIO MEDICA CORPORATION 10-RSV-065 RDS

Easy Lab Pro RSV - US

BD Veritor™ System For Rapid Detection of RSV Contains: 30 RSV Devices, 30 RV Reagent D in unitized tubes, 30 individually wrapped, sterile minitip sampling swabs and one each of RSV+ Control, RSV- Control

BD Veritor™ System For Rapid Detection of RSV Contains: 30 Reactive strips, 30 RV Reagent C in unitized tubes, 30 plastic transfer pipettes, and one each of RSV+ Control, RSV - Control

TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

RSV Test Kit US Version 135060

UNIVERSAL PATIENT RESTRAINT STRAP

Easy Lab Pro RSV - US

BD Veritor™ System For Rapid Detection of RSV Contains: 30 RSV Devices, 30 RV Reagent D in unitized tubes, 30 individually wrapped, sterile minitip sampling swabs and one each of RSV+ Control, RSV- Control

BD Veritor™ System For Rapid Detection of RSV Contains: 30 Reactive strips, 30 RV Reagent C in unitized tubes, 30 plastic transfer pipettes, and one each of RSV+ Control, RSV - Control

TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate, and nasal and nasopharyngeal swab samples. It is designed to be used by clinical laboratories to test specimens from symptomatic patients aged five years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture. The results of this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.