Address:7600 NW 69th Ave,Medley,FL,33166,US
Device Description : PCRopsis™ Support (1 mL) helps mediate select Next Gen Direct PCR™ applications PCRopsis™ Support (1 mL) helps mediate select Next Gen Direct PCR™ applications (e.g., PCR amplification from urine)
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Support (0.25 mL) helps mediate select Next Gen Direct PCR™ applicatio PCRopsis™ Support (0.25 mL) helps mediate select Next Gen Direct PCR™ applications (e.g., PCR amplification from urine)
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Universal Viral Transport is intended for the collection and non-propa PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Universal Viral Transport is intended for the collection and non-propa PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Universal Viral Transport is intended for the collection and non-propa PCRopsis™ Universal Viral Transport is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory.
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (3 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
Device Class : 1
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non PCRopsis™ Universal Viral Transport (UVT) is intended for the collection and non-propagating transport of clinical specimens containing viruses, chlamydiae, mycoplasmas or ureaplasmas from the collection site to the testing laboratory. PCRopsis™ UVT (1.5 mL) is aliquoted into 100x sterile, 10 mL transport tubes.
Device Class :
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : Four NuTec slides used to create bio-molecular profiles of samples
Device Class : 2
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : Additive used in preparing OpsisDx urine fixative and OpsisDx standard media
Device Class : 2
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No
Device Description : Media used for quality control of the OpsisDx platform
Device Class : 2
Duns Number: 078294784
Premarket Exempt : Yes
Prescription Use : No