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11,969 catalysts · 3,382 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma
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11,969 catalysts · 3,382 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with each individual Lumipulse G assay. Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio, Item# CL0073 is comprised of the following kits, which are imported: Kit Description, Item#: Imported from Fujirebio Europe (FRE): Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550 Lumipulse G pTau 217 Plasma Calibrators set 81557 Lumipulse pTau 217 Plasma Controls 81558 Lumipulse ¿-Amyloid Plasma Controls 81559 Imported from Fujirebio Japan (FRI): Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges 235447 Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators set 235454 Component: No — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse ¿-Amyloid Plasma Controls: Liquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-¿-amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-¿-amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy. — Reason: Potential for microbial contamination. — Status: Ongoing
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 ¿ 1.5 mL (4 Concentrations) CAL 1 0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 3 100 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 4 1000 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 950. Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio — Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result). — Status: Ongoing
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: MICRO LABS LTD INDIA. Form: TABLET. Route: ORAL
Sponsor: LEO PHARMA AS. Form: INJECTABLE. Route: INJECTION
Sponsor: DECIPHERA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ENTASIS THERAP. Form: FOR SUSPENSION. Route: ORAL
Sponsor: MYLAN LABS LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: AMPHASTAR PHARMS INC. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LIB THERAPEUTICS, INC.. Form: INJECTABLE. Route: INJECTION
Sponsor: PFIZER. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: SUN PHARMA GLOBAL. Form: INJECTABLE. Route: INJECTION
Sponsor: AMNEAL. Form: TABLET. Route: ORAL
Sponsor: MILESTONE PHARMS USA. Form: SPRAY. Route: NASAL
Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL
Sponsor: SPECTRUM PHARMS. Form: INJECTABLE. Route: SUBCUTANEOUS
Product code: FRG. Advisory committee: General Hospital. Type: Traditional
Product code: DTZ. Advisory committee: Cardiovascular. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: MEG. Advisory committee: General Hospital. Type: Traditional
Product code: QSY. Advisory committee: Unknown. Type: Special
Product code: LNH. Advisory committee: Radiology. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JOW. Advisory committee: Cardiovascular. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Special
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional
Product code: QXM. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: NHN. Advisory committee: Physical Medicine. Type: Traditional
Product code: SCA. Advisory committee: Microbiology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30