Address:MUSTIONKATU 6,TURKU Varsinais-Suomi,FI
Device Description : Panthera-Puncher 9 is a sample transfer instrument for professional use. The sam Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Panthera-Puncher 9 is cabable of handling up to 9 pcs of 96-well microtiter plates simultaneously. Panthera-Puncher contains a camera for imaging of the sample card and for blood detection.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : For the quantitative determination of total galactose concentration in dried blo For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : For the quantitative determination of human biotinidase activity in dried blood. For the quantitative determination of human biotinidase activity in dried blood. Note: Kit contains multiple packages.
Device Class : 2
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : No
Device Description : Polymerase chain reaction (PCR) based assay for semiquantitative determination o Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
Device Class : 2
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : Polymerase chain reaction (PCR) based assay for semiquantitative determination o Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
Device Class : 2
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : Polymerase chain reaction (PCR) based assay for semiquantitative determination o Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.
Device Class : 2
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : Yes
Device Description : The chemagic Prepito-D is an automated laboratory instrument used in preanalytic The chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The VICTOR EnLite instrument is intended for the quantitative determination of T The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The VICTOR EnLite instrument is intended for the quantitative determination of T The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit.
Device Class : 1
Duns Number: 540156544
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® System (SP and PP).
Device Class : 1
Duns Number: 540156544
Premarket Exempt : No
Prescription Use : No