Description
Created On: 2020-07-15
Record Count: 4
Primary Industries
- Medical
- Diagnostic
- Device
IPSCIO Report Record List
Below you will find the records curated into this collection. This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs. The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms. For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report
IPSCIO Record ID: 28762
Licensor grants Licensee a non-exclusive License to make, use, develop, have developed, manufacture, have manufactured, offer to sell, sell and have sold Licensed Products utilizing blood, serum, plasma, or urogenital swab as the sample material under the Licensee brand name.
Licensed Technology shall mean human in vitro clinical diagnostic and non-therapy screening rapid test and sample applicator device technology described in European Patent Application 04003603.0 and corresponding foreign counterparts thereof; Finnish Patent Application FI200040825 and all issues, reissues, amendments divisions, continuations, continuations-in-part, and corresponding foreign counterparts thereof; and all confidential know-how proprietary to Licensor needed to assist Licensee in developing and manufacturing Licensed Products.
The use is the worldwide professional and OTC human in vitro clinical diagnostic markets.
IPSCIO Record ID: 6962
Assignor hereby grants Assignee the right to use and display Assignor's trademarks, service marks, and trademarks and trade names that are applicable to Assignor Product(s) under this private labeling agreement. Assignee may use any of Assignor's Marks as part of its corporate, trade or other business name.
FDA 510K Numbers and Approved Tests
Device Name
510(K) Number
Rubella-Cube
K892051
CMV-Cube
K884842
Rotacube (Rotavirus)
K884017
Blue Dot Test for Pregnancy
K882588
First Sign (Pregnancy, HCG)
K973208
V-Trend Target IM Test (Infectious Mononucleosis)
K890041
Target Strep A
K880460
Target HCG Enzyme Immunoassay Reagents
K862247
Target ASO Test
K910073
Target HCG Test
K914303
Target HCG One-Step
K903937
V-Trend Target RF Test
K904105
Target Quantitative HCG
K890131
V-Trend Target CRP Test
K890423
Target Reader
K885254
510(K) Approved Platform Products
HCG: Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.
Strep A: Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.
Rubella: Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.
CMV: Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections pose a very significant risk in infants and immunocomprised patients.
Rotavirus: Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.
Mono: Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.
CRP: C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.
Reader: The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.
IPSCIO Record ID: 266
FDA 510K Numbers & Approved Tests
Device Name
510(K) Number
Rubella-Cube
K892051
CMV-Cube
K884842
Rotacube (Rotavirus)
K884017
Blue Dot Test for Pregnancy
K882588
First Sign (Pregnancy, HCG)
K973208
V-Trend Target IM Test (Infectious Mononucleosis)
K890041
Target Strep A
K880460
Target HCG Enzyme Immunoassay Reagents
K862247
Target ASO Test
K910073
Target HCG Test
K914303
Target HCG One-Step
K903937
V-Trend Target RF Test
K904105
Target Quantitative HCG
K890131
V-Trend Target CRP Test
K890423
Target Reader
K885254
510(K) Approved Platform Products
HCG: Human chorionic gonadotropin (Pregnancy Test) Rapid enzyme immunoassay test for qualitative detection of HCG in urine, serum and plasma. HCG is a hormone produced by the developing placenta. Serum and urine levels of HCG climb rapidly, starting as soon as the week following implantation, reaching peak levels near the end of the first trimester. One-step technology offers superior speed and simplicity without sacrificing sensitive and specific results.
Strep A: Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.
Rubella: Rapid enzyme immunoassay test for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage to the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects. Therefore, all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.
CMV: Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections a very significant risk in infants and immunocomprised patients.
Rotavirus: Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenterics in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocmial infection.
Mono: Qualitative and quantitative detection of heterophile antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient’s serum, usually 1 to3 weeks after the onset of symptoms Common symptoms include fatigue, pharyngitis, fever, lymphadenopatherapy and splenomegaly.
CRP: C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if monitored on a daily basis. CRP is also predictive of clinical cardiovascular disease.
Reader: The Target System Reader is designed to interpret selected membrane enzyme immunoassays. The instrument is designed for laboratory, emergency room or field use and requires only a few minutes to learn to operate. The reader permits more precise, accurate readings of test results than visual interpretation.
Such testing to be done at the point of care, such point of care may include but are not limited to places such as:
·
Hospitals
·
Emergency Medical Vehicle Care
·
Mobile Health Clinics
·
Schools
·
Government Agencies
·
Retail Drug Stores
·
Corporations
·
Hospices
·
Assisted Living and Nursing Homes
·
Home Health Care
·
Physician’s offices
IPSCIO Record ID: 287575
The Company is an in vitro diagnostics company that has developed an innovative and proprietary technology platform that offers a rapid, sensitive and simple alternative to existing diagnostic methodologies. The Company is using its T2 Magnetic Resonance technology (“T2MRâ€) to develop a broad set of applications aimed at lowering mortality rates, improving patient outcomes and reducing the cost of healthcare by helping medical professionals make targeted treatment decisions earlier.