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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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InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004311
In Commercial Distribution

  • 03610520267226 ()
12004311

  • Homocysteine IVD, control
InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004310
In Commercial Distribution

  • 03610520267219 ()
12004310

  • Homocysteine IVD, control
InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.)
BIO-RAD LABORATORIES, INC.
12004309
In Commercial Distribution

  • 03610520242582 ()
12004309

  • Homocysteine IVD, control
Liquichek Immunology Control Level 1 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003784
In Commercial Distribution

  • 03610520174388 ()
12003784

  • Multiple-type clinical chemistry analyte profile IVD, control
Liquichek Immunology Control Level 3 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003786
In Commercial Distribution

  • 03610520174371 ()
12003786

  • Multiple-type clinical chemistry analyte profile IVD, control
Liquichek Immunology Control Level 2 (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003785
In Commercial Distribution

  • 03610520174364 ()
12003785

  • Multiple-type clinical chemistry analyte profile IVD, control
Liquichek Immunology Control MiniPak (A human serum assayed protein control.)
BIO-RAD LABORATORIES, INC.
12003787
In Commercial Distribution

  • 03610520174357 ()
12003787

  • Multiple-type clinical chemistry analyte profile IVD, control
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.
LUMINEX CORPORATION
20-011-024
In Commercial Distribution

20-011-024

  • 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).
LUMINEX CORPORATION
20-011-022
In Commercial Distribution

20-011-022

  • 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.
LUMINEX CORPORATION
20-011-021
In Commercial Distribution

20-011-021

  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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