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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No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065
In Commercial Distribution

  • 00867556000188 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066
In Commercial Distribution

  • 00867556000157 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 Tests
Siemens Healthcare Diagnostics Inc.
10464339
In Commercial Distribution

  • 00842768027918 ()
  • 00630414005577 ()
K3032

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444895
In Commercial Distribution

  • 00842768013898 ()
  • 00630414003863 ()
RF520

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10444904
In Commercial Distribution

  • 00842768013829 ()
  • 00630414003924 ()
RF420

  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.
BIOMERIEUX SA
30421-01
Not in Commercial Distribution

  • 03573026161613 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
MDNG-5121 BB MA GE BUC MKII
Barco NV
MDNG-5121
Not in Commercial Distribution

  • 05415334001473 ()
K9300268B

  • Radiology picture archiving and communication system workstation
SAFARI 900, BTE 13 P BB
Oticon A/S
103-40-305-00
In Commercial Distribution

  • 05707131149671 ()


  • Air-conduction hearing aid, behind-the-ear
SAFARI 600, BTE 13 P BB
Oticon A/S
103-40-405-00
In Commercial Distribution

  • 05707131149497 ()


  • Air-conduction hearing aid, behind-the-ear
SAFARI 300, BTE 13 P BB
Oticon A/S
103-40-505-00
In Commercial Distribution

  • 05707131149312 ()


  • Air-conduction hearing aid, behind-the-ear
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