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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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Aurix Eight Pack Kit Case of 8 Wound Dressing Kits and 8 Reagent Kits with 010512 Aurix Eight Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-08
In Commercial Distribution

  • 10852714003146 ()


  • Wound dressing kit, medicated
Aurix Five Pack Kit Case of 5 Wound Dressing Kits and 5 Reagent Kits with 010503 Aurix Five Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-05
In Commercial Distribution

  • 10852714003139 ()


  • Wound dressing kit, medicated
Aurix Single Pack Kit Single Kit with 010405 Aurix Single Pack Kit Label
Nuo Therapeutics, Inc.
AUSP-01
In Commercial Distribution

  • 10852714003122 ()


  • Wound dressing kit, medicated
Aurix Wound Dressing Kit Case of 10 Kits or 10 Trays with 010374 Case Label for AGSW-02
Nuo Therapeutics, Inc.
AGSW-02
In Commercial Distribution

  • 10852714003108 ()


  • Wound dressing kit, medicated
A blood bag temperature monitor for use by health care providers to determine if blood or blood products have reached or exceeded the indication temperature.
Temptime Corporation
STV10
In Commercial Distribution

  • 20852282007147 ()
  • 10852282007140 ()
  • 00852282007143 ()
7201-50

  • Medical product temperature point indicator, thermochemical
The Grifols Diluent is for use in preparing human red blood cell suspensions and plasma/serum dilutions used with the DG Gel 8 cards. For in vitro diagnostic use.
DIAGNOSTIC GRIFOLS SA
213677
In Commercial Distribution

  • 08437014205244 ()
  • 08437014205251 ()
213677

  • Wash/cleaning solution IVD, automated/semi-automated system
DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.
DIAGNOSTIC GRIFOLS SA
213734
In Commercial Distribution

  • 08437014205169 ()
213734

  • Microplate/tube/assay card incubator IVD
DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards.
DIAGNOSTIC GRIFOLS SA
210363
In Commercial Distribution

  • 08437014205152 ()
210363

  • Gel column agglutination centrifuge IVD
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)
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210404
Not in Commercial Distribution

  • 08436583730980 ()
210404

  • Blood bank information system application software
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