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This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution
- 00852720008008 ()
G106ac-1
- Cystic fibrosis IVD, control
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution
- 00857573006348 ()
- Multiple coagulation factor IVD, kit, clotting
The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
41
In Commercial Distribution
- 00856181003411 ()
- Headphones
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution
- 00851034007011 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution
- 00851458005266 ()
DFA2-ASY-0012
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
BIOFIRE DEFENSE, LLC
DFA2-ASY-0004
In Commercial Distribution
- 00851458005242 ()
DFA2-ASY-0004
- Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0007
In Commercial Distribution
- 00851458005136 ()
NGDS-ASY-0007
- Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
ABAXIS, INC.
400-0031
In Commercial Distribution
- EABA40000311 ()
- EABA40000310 ()
400-0031
- Total lactate dehydrogenase (LDH) IVD, reagent
- Magnesium (Mg2+) IVD, reagent
- Chloride (Cl-) IVD, reagent
- Sodium (Na+) IVD, control
- Bicarbonate (HCO3-) IVD, reagent
- Potassium (K+) IVD, reagent
- Calcium (Ca2+) IVD, reagent
- Urea IVD, reagent
- Creatinine IVD, reagent
- Glucose IVD, reagent
9 Panel Drug Test Cup
AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
UCP BIOSCIENCES, INC.
U-CUP-794
In Commercial Distribution
- 20817038022270 ()
- 10817038022273 ()
- 00817038022276 ()
U-CUP-794
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-13104
In Commercial Distribution
- 00817038022252 ()
- 10817038022259 ()
- 20817038022256 ()
U-CUP-13104
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Cup
AMP/BUP/BZO/COC/MOP/OXY
with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-CUP-2064-3AD
In Commercial Distribution
- 20817038022072 ()
- 10817038022075 ()
- 00817038022078 ()
U-CUP-2064-3AD
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
30-001-001
- Multiple coagulation factor IVD, kit, clotting
The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Luminex Molecular Diagnostics, Inc
I051C0447
In Commercial Distribution
- 00840487100417 ()
I051C0447
- Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Strip description for the invitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples
ARKRAY USA, INC.
77123
Not in Commercial Distribution
- 00015482771232 ()
- 50015482771237 ()
- Magnesium (Mg2+) IVD, kit, spectrophotometry
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423742
In Commercial Distribution
- 00815381020529 ()
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution
- 00815381020079 ()
RFIT-ASY-0125
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution
- 00815381020062 ()
RFIT-ASY-0124
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Aktina Corp.
11-202
In Commercial Distribution
- B365112020 ()
- Radiological whole-body positioner
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution
- 00817830022818 ()
- Length: 75 Millimeter
07RD-7110-22
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
ACCUTRON, INC.
49054
In Commercial Distribution
- 00813830024845 ()
49054
- Medical gas pipeline system