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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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Vysis CLL FISH Probe Kit
ABBOTT MOLECULAR INC.
04N02-020
In Commercial Distribution

  • 00884999007772 ()
04N02-020

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Abbott m2000rt Optical Calibration Kit
ABBOTT MOLECULAR INC.
04J71-93
In Commercial Distribution

  • 00884999006577 ()
04J71-93

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
2N40-80
In Commercial Distribution

  • 00884999003064 ()
2N40-80

  • Hepatitis B virus nucleic acid IVD, control
Abbott RealTime HBV Calibrator Kit
ABBOTT MOLECULAR INC.
2N40-70
In Commercial Distribution

  • 00884999003057 ()
2N40-70

  • Hepatitis B virus nucleic acid IVD, calibrator
Abbott RealTime HCV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
1N30-90
In Commercial Distribution

  • 00884999000728 ()
1N30-90

  • Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HCV Control Kit
ABBOTT MOLECULAR INC.
1N30-80
In Commercial Distribution

  • 00884999000711 ()
1N30-80

  • Hepatitis C virus nucleic acid IVD, control
Abbott RealTime HCV Calibrator Kit
ABBOTT MOLECULAR INC.
1N30-70
In Commercial Distribution

  • 00884999000704 ()
1N30-70

  • Hepatitis C virus nucleic acid IVD, calibrator
ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle
MICERIUM SPA
CPCK
In Commercial Distribution

  • EMICCPCK1 ()
CPCK

  • Glass ionomer dental cement
  • Dental prosthesis-component adhesive
ENA-BOND SE KIT Bonding + Primer -1 CFOTS-2 (2 ml) -1 CFOTP-2 (2 ml)
MICERIUM SPA
CFOTX
In Commercial Distribution

  • EMICCFOTX1 ()

  • Total Volume: 4 Milliliter
CFOTX

  • Dentine bonding agent/set
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