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Adapter for navigation probe, to be used with RIWOtrack Clipsensor, component of RIWOtrack Navigation System
Fiagon GmbH
N011959
In Commercial Distribution
- 04260759930089 ()
N011959
- Multi-purpose stereotactic surgery system
Adapter for navigation probe, to be used with RIWOtrack Flexsensor, component of RIWOtrack Navigation System
Fiagon GmbH
N011949
In Commercial Distribution
- 04260759930072 ()
N011949
- Multi-purpose stereotactic surgery system
MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as well as associated antimicrobial resistance genes, by the BioFire® FilmArray® Blood Culture Identification 2 (BCID2) Panel on FilmArray® systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus influenza, Neisseria meningitides, Pseudomonas aeruginosa, Stenotrophomonas maltophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-48-like, VIM, mcr-1. Control 2 - GPY: Gram positive bacteria: Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunesis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatti; antimicrobial resistance genes: mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.
STRECK, INC.
250065
In Commercial Distribution
- 00844509002338 ()
- Total Volume: 1.0 Milliliter
250065
- Multiple-type bloodstream pathogen nucleic acid IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of PLT L1-6.
STRECK, INC.
291720
In Commercial Distribution
- 00844509001591 ()
- Total Volume: 3.0 Milliliter
291720
- Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of WBC L1-5.
STRECK, INC.
291719
In Commercial Distribution
- 00844509001584 ()
- Total Volume: 3.0 Milliliter
291719
- Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-5, WBC L1-5, PLT L1-6.
STRECK, INC.
291718
In Commercial Distribution
- 00844509001577 ()
- Total Volume: 3.0 Milliliter
291718
- Full blood count IVD, control
Assayed linearity control kits that are used to determine the patient reportable range of 3-part and 5-part hematology instruments. Contains 1 vial each of RBC L1-4, WBC L1-4, PLT L1-4.
STRECK, INC.
291715
In Commercial Distribution
- 00844509001560 ()
- Total Volume: 3.0 Milliliter
291715
- Full blood count IVD, control
MDx-Chex™ for BC-GP is intended for use as an external positive and negative assayed control to monitor the
performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance
genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex
VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered
solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components.
Positive Control: Gram-positive bacteria: Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus
lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Enterococcus faecalis,
Enterococcus faecium, Streptococcus anginosus group; Species: Staphylococcus spp., Streptococcus spp., Listeria spp.;
antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product
is not intended to replace manufacturer controls provided with the device.
STRECK, INC.
250079
In Commercial Distribution
- 00844509002468 ()
250079
- Multiple-type bloodstream pathogen nucleic acid IVD, control
MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor
the performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobial
resistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on
Luminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composed
of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media
components. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella
oxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spp., Citrobacter spp., Enterobacter spp., Proteus
spp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: buffered
solution only. This product is not intended to replace manufacturer controls provided with the device.
STRECK, INC.
250080
In Commercial Distribution
- 00844509002437 ()
250080
- Multiple-type bloodstream pathogen nucleic acid IVD, control
Urinalysis control designed specifically for the Sysmex® UF-1000i™ urine analyzer. Contains 1 vial each of Level 1 & 2.
STRECK, INC.
213465
In Commercial Distribution
- 00844509001997 ()
- Total Volume: 45 Milliliter
213465
- Urine sediment IVD, control