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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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SW MMT-8061 INPEN 2.0 ANDROID APP US
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000974596 ()


  • Empty self-injector, mechanical
SW MMT-8060 INPEN 2.0 IOS APP US
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000974589 ()


  • Empty self-injector, mechanical
SFTWR CSS7201 GRDN MBL APP ANDRD V4.1.1
MEDTRONIC MINIMED, INC.
CSS7201
In Commercial Distribution

  • 00763000381097 ()


  • Patient health record information system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
Not in Commercial Distribution

  • 07392532242373 ()
75750

  • Rectal irrigation system application software
SFTWR MMT-8100 IOS WATSON APP V3.0 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000168643 ()


  • Self-care monitoring/reporting software
SFTWR CSS7200 GRDN MBL APP IOS V3.2.3
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000186333 ()


  • Patient health record information system application software
SFTWR MMT-8100 IOS WATSON APP V2.1 UDI
MEDTRONIC MINIMED, INC.
MMT-8100
In Commercial Distribution

  • 00763000086619 ()


  • Self-care monitoring/reporting software
Hemo-QC simulates blood samples and is intended for the daily quality control of routine blood bank reagents used in manual, semi-automated and automated blood typing and antibody screen test systems.
HEMO BIOSCIENCE INC
H9200
In Commercial Distribution

  • 00858352006009 ()
H9200

  • Multiple blood group genotyping IVD, control
The ID CORE CONTROL kit consists of 2 sets of recombinant synthetic DNA plasmids to be used as positive controls to evaluate the performance of the ID CORE XT test(Kit Product Number: 1021720000). The ID CORE CONTROL kit contains two separate vials: ID CORE CONTROL 1 and ID CORE CONTROL 2, both composed of synthetic plasmid pools to be used as assayed positive controls for alternate alleles (alleles 1 and 2, respectively) of the 29 polymorphisms assayed by ID CORE XT. Both control vials must be used in every run of the ID CORE XT test as positive controls for the correct detection of the polymorphism genotypes interrogated by the test. Each control has expected polymorphism genotypes results in the ID CORE XT test when analyzed by the ID CORE XT ANALYSIS SOFTWARE and will produce a valid or invalid run result. ID CORE XT is a qualitative, polymerase chain reaction (PCR) and hybridization-based genotyping test for the simultaneous identification of multiple alleles encoding human erythrocyte antigens (HEAs) in human genomic DNA. ID CORE XT interrogates 29 polymorphisms to predict 53 HEA allele genotypes and 37 antigen phenotypes of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, as an alternative to serology.
PROGENIKA BIOPHARMA, SA
v1
In Commercial Distribution

  • 08437013457040 ()
1301790000

  • Multiple blood group genotyping IVD, control
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