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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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HnA3 2g×5
KURARAY NORITAKE DENTAL INC.
108-0731KA
In Commercial Distribution

  • EKUR1080731KA0 ()


  • Dental appliance fabrication material, ceramic
HnA2 5g×5
KURARAY NORITAKE DENTAL INC.
108-0722KA
In Commercial Distribution

  • EKUR1080722KA0 ()


  • Dental appliance fabrication material, ceramic
HnA2 2g×5
KURARAY NORITAKE DENTAL INC.
108-0721KA
In Commercial Distribution

  • EKUR1080721KA0 ()


  • Dental appliance fabrication material, ceramic
HnA1 5g×5
KURARAY NORITAKE DENTAL INC.
108-0712KA
In Commercial Distribution

  • EKUR1080712KA0 ()


  • Dental appliance fabrication material, ceramic
HnA1 2g×5
KURARAY NORITAKE DENTAL INC.
108-0711KA
In Commercial Distribution

  • EKUR1080711KA0 ()


  • Dental appliance fabrication material, ceramic
LNW0.5 5g×5
KURARAY NORITAKE DENTAL INC.
108-0702KA
In Commercial Distribution

  • EKUR1080702KA0 ()


  • Dental appliance fabrication material, ceramic
LNW0.5 2g×5
KURARAY NORITAKE DENTAL INC.
108-0701KA
In Commercial Distribution

  • EKUR1080701KA0 ()


  • Dental appliance fabrication material, ceramic
LNW0 5g×5
KURARAY NORITAKE DENTAL INC.
108-0692KA
In Commercial Distribution

  • EKUR1080692KA0 ()


  • Dental appliance fabrication material, ceramic
Tissue 5 10g
KURARAY NORITAKE DENTAL INC.
107-1391KA
In Commercial Distribution

  • EKUR1071391KA0 ()


  • Dental appliance fabrication material, ceramic
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.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
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