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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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This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-170M-PA
Not in Commercial Distribution

  • 04987905300120 ()


  • Carbon dioxide laboratory incubator
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-5M-PA
Not in Commercial Distribution

  • 04987905300113 ()


  • Carbon dioxide laboratory incubator
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-230AICUV-PA
Not in Commercial Distribution

  • 04987905300090 ()


  • Carbon dioxide laboratory incubator
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-19MUV-PA
Not in Commercial Distribution

  • 04987905300076 ()


  • Carbon dioxide laboratory incubator
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-19M-PA
Not in Commercial Distribution

  • 04987905300069 ()


  • Carbon dioxide laboratory incubator
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
PHC CORPORATION
MCO-170AICUV-PA
Not in Commercial Distribution

  • 04987905300045 ()


  • Carbon dioxide laboratory incubator
The DRI™ Fentanyl II Assay (Thermo Fisher) is an immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL.
ARK DIAGNOSTICS INC
10028871
In Commercial Distribution

  • 00812101030769 ()
10028871

  • Fentanyl IVD, kit, enzyme immunoassay (EIA)
The ARK™ AB-PINACA Assay is an immunoassay intended for the qualitative determination of AB-PINACA and their metabolites in human urine at a cutoff concentration of 5 ng/mL.
ARK DIAGNOSTICS INC
5055-0001-00
In Commercial Distribution

  • 00812101030349 ()
5055-0001-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Calcium CPC Reagent Set for the quantitative determination of calcium in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 7 x 100ml, 3 x 100ml
POINTE SCIENTIFIC, INC.
HC902-1000
In Commercial Distribution

  • 00811727012609 ()
HC902-1000

  • Calcium (Ca2+) IVD, reagent
Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml
POINTE SCIENTIFIC, INC.
HA965-324
In Commercial Distribution

  • 00811727012562 ()
HA965-324

  • Total amylase IVD, kit, spectrophotometry
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