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The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The OSOM Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Cross-reactivity with respiratory viruses other than influenza viruses has not been evaluated. The user is responsible for determining the cross-reactivity of other respiratory viruses with this test.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

Reagents: For the quantitative measurement of C-Reactive Protein (CRP) concentration in serum or plasma. For In Vitro Diagnostic Use. Calibrator: For the calibration of the N-geneousTM Wide Range CRP assay. For In Vitro Diagnostic Use.

The Genzyme N-geneous™ Wide Range CRP Reagent is a two-reagent method for the quantitative measurement of CRP concentration from 0.04 to 320 mg/L in serum or plasma. The test is an enhanced latex-agglutination turbidimetric immunoassay. Sample is added to a buffer solution and mixed with a suspension of mouse anti-human CRP monoclonal antibody, which is bound to latex. CRP binds to the latex-bound antibody, which agglutinates. The light scattering caused by the increase in particle size is used as a measure of CRP concentration. The amount of light scattering is proportional to the concentration of CRP in the sample. N-geneous™ Wide Range CRP Calibrator Set is a stabilized human serum designed to be used to calibrate the N-geneous™ Wide Range CRP Reagent and is sold separately.

Sepramesh™ IP Bioresorbable Coating - Permanent Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Sepramesh™ IP Bioresorbable Coating - Permanent Mosh (Sepramesh™ IP) is a dualcomponent (absorbable and non-absorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. Sepramesh™ IP is co-knitted using polypropylene and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a polypropylene surface and PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and a polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, encouraging tissue ingrowth, similar to polypropylene mesh alone. The visceral side of the mesh provides a hydrophilic bioresorbable layer, separating the mesh from underlying tissue and organ surfaces during the critical wound-healing period resulting in minimal tissue attachment and visceral adhesions to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days. The absorption of the PGA fibers is essentially complete between 50 and 80 days. The polypropylene mesh is permanent and allows for tissue ingrowth.

The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis ("Trichomonas") antigens from vaginal swabs and from the saline solution prepared when making wet mounts from vaginal swabs. This test is intended for use in patients with symptoms of vaginosis/vaginitis or suspected exposure to the Trichomonas pathogen. This device is intended for use in physicians' offices as well as clinical laboratories.

The OSOM Trichomonas Rapid Test uses color immunochromatographic, capillary flow, "dipstick" technology with antibodies coated on a nitrocellulose membrane. The test procedure requires the solubilization of Trichomonas proteins from a vaginal swab by placing it in a Sample Buffer. The OSOM Trichomonas Rapid Test is then placed in the Sample Buffer, and the mixture migrates along the membrane surface. If Trichomonas is present in the sample, it will form a complex with the primary anti-Trichomonas antibody conjugated to colored particles (blue). The complex will then be bound by the second anti-Trichomonas capture antibody. The appearance of a visible blue test line together with the red control line indicates a positive result.

The Contrast® II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

The Genzyme Diagnostics Contrast® II hCG Urine/Serum test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories. The Contrast® II Urine/Serum device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume AccuPipette® provided. The sample migrates through reaction pads where hCG. if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled monoclonal antibody-hCG complex is captured at a test line region containing immobilized monoclonal anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

Reagent: For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). For In Vitro Diagnostic Use. Calibrator: For calibration of the Ultra HDL Cholesterol assay. For In Vitro Diagnostic Use.

The new Ultra N-geneous® HDL Cholesterol Kit is a two-reagent homogeneous method for the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The new Ultra N-geneous® HDL Cholesterol assay does not contain polyanion or divalent metal. "precipitation reagent". This new method is based on accelerating the reaction of cholesterol oxidase and dissolving HDL selectively using a specific detergent.

Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic orthopedic and neurological procedures.

Polyester Nonabsorbable Surgical Suture, USP size 9-0 through 9 available as undyed, dyed D & C Green No. 6 and as a co-braid of the undyed and dyed. The suture is sterile, braided and is provided in a variety of lengths, with or without pledgets, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

HylaSine™, hylan B gel is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. This hyaluranon is a bioresorbable material that functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine sinus surgery. HylaSine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

Intended Use: For the quantitative determination of α-Amylase activity in human serum or plasma. Indications for Use: Levels of serum and plasma α-amylase in patients have provided needed evidence for the diagnosis of acute pancreatitis. For In Vitro Diagnostic Use.

The Genzyme Direct Amylase Reagent is a quantitative method for the detection of a-amylase activity in serum and plasma.