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No Description
BIOCARE MEDICAL LLC
HFA7309A
In Commercial Distribution
- 00847627000460 ()
- Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
HFA7307A
In Commercial Distribution
- 00847627000446 ()
- Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
HFA7298A
In Commercial Distribution
- 00847627000422 ()
- Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
HFA7282A
In Commercial Distribution
- 00847627000408 ()
- Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
HFA7281A
In Commercial Distribution
- 00847627000392 ()
- Nucleic acid hybridization detection IVD, probe
No Description
BIOCARE MEDICAL LLC
HFA7279A
In Commercial Distribution
- 00847627000385 ()
- Nucleic acid hybridization detection IVD, probe
TRANSCYTE® is a human fibroblast-derived temporary skin substitute
consisting of a polymer membrane and donated neonatal human
fibroblast cells cultured under aseptic conditions in vitro on a nylon
mesh. Prior to cell growth, this nylon mesh is coated with porcine
dermal collagen and bonded to a polymer membrane (silicone). This
membrane provides a transparent synthetic epidermis when applied.
As fibroblasts proliferate within the nylon mesh, they secrete human
dermal collagen, matrix proteins and growth factors. Following freezing,
no cellular metabolic activity remains; however, the tissue matrix and
bound growth factors are left intact. The human fibroblast-derived
temporary skin substitute provides a temporary protective barrier.
TRANSCYTE is transparent and allows direct visual monitoring of the
wound bed.
ORGANOGENESIS INC.
10633
In Commercial Distribution
- 00618474000046 ()
- Skin regeneration template, human-/animal-derived
The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
NANOSPHERE, INC.
20-011-024
Not in Commercial Distribution
- 00857573006324 ()
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution
- 00857573006317 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
NANOSPHERE, INC.
20-011-021
Not in Commercial Distribution
- 00857573006300 ()
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry