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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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ID CORE XT (Reagents and Analysis Software) 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 genomic DNA extracted from whole blood specimens collected in EDTA. This test can be used to genotype 29 polymorphisms and predict 37 HEA phenotypes of blood group systems Rh (CW, C, c, E, e, VS, V, hrB, hrS), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Kidd (Jka, Jkb), Duffy (Fya, Fyb), MNS (M, N, S, s, U, Mia), Diego (Dia, Dib), Dombrock (Doa, Dob, Hy, Joa), Colton (Coa, Cob), Cartwright (Yta, Ytb), and Lutheran (Lua, Lub) as an alternative to serology. The ID CORE XT test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. ID CORE XT generates a simultaneous multiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is a polymorphism genotype, a predicted allele genotype and a predicted phenotype, bypassing any subjective interpretation of the results.
PROGENIKA BIOPHARMA, SA
v3
In Commercial Distribution

  • 08437013457019 ()
1021720000

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20202-08
In Commercial Distribution

  • 10888234100065 ()
800-20202-08

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-20236
In Commercial Distribution

  • 10888234102632 ()
800-20236

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-20202-96
In Commercial Distribution

  • 10888234102618 ()
800-20202-96

  • Multiple blood group genotyping IVD, nucleic acid technique (NAT)
No Description
BIOARRAY SOLUTIONS LTD
800-00229
In Commercial Distribution

  • 10888234102328 ()
800-00229

  • Multiple blood group genotyping IVD, control
No Description
BIOARRAY SOLUTIONS LTD
800-00228
In Commercial Distribution

  • 10888234102298 ()
800-00228

  • Multiple blood group genotyping IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
Not in Commercial Distribution

  • 00856626006120 ()
995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
In Commercial Distribution

995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
Reusable SpO2 Sensor/Philips/大号Soft finger cover/Adult/3.0M/087/Tracelogix Corporation
Unimed Medical Supplies, Inc.
TL122113A300B-CA652
In Commercial Distribution

  • 06945664810432 ()


  • Pulse oximeter probe, reusable
No Description
BIOARRAY SOLUTIONS LTD
800-10242
In Commercial Distribution

  • 10888234100928 ()
800-10242

  • Multiple blood group genotyping IVD, reagent
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