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17,942 catalysts · 4,728 grant · 3,609 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,942 catalysts · 4,728 grant · 3,609 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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
Supplement type: 30-Day Notice. Product code: QXB. Advisory committee: GU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30