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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Quidel Triage Total 5 Control 1
QUIDEL CARDIOVASCULAR INC.
88753
In Commercial Distribution

  • 30014613337102 ()
88753

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 2
QUIDEL CARDIOVASCULAR INC.
88734
In Commercial Distribution

  • 30014613337096 ()
88734

  • Multiple cardiac marker IVD, control
Quidel Triage Total 3 Control 1
QUIDEL CARDIOVASCULAR INC.
88733
In Commercial Distribution

  • 30014613337089 ()
88733

  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K982M-5
In Commercial Distribution

  • B085K982M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K936M-5
In Commercial Distribution

  • B085K936M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K935M-5
In Commercial Distribution

  • B085K935M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K908M-5
In Commercial Distribution

  • B085K908M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K906M-5
In Commercial Distribution

  • B085K906M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K891M-5
In Commercial Distribution

  • B085K891M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K887M-5
In Commercial Distribution

  • B085K887M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K804M-5
In Commercial Distribution

  • B085K804M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K710M-5
In Commercial Distribution

  • B085K710M50 ()


  • Multiple cardiac marker IVD, control
No Description
AALTO SCIENTIFIC
K026M-6
In Commercial Distribution

  • B085K026M60 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014182
In Commercial Distribution

  • 00884883004399 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014181
In Commercial Distribution

  • 00884883004382 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014180
In Commercial Distribution

  • 00884883004375 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
10014179
In Commercial Distribution

  • 00884883004368 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLS
In Commercial Distribution

  • 00884883003613 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL4
In Commercial Distribution

  • 00884883003606 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XLL
In Commercial Distribution

  • 00884883002371 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL3
In Commercial Distribution

  • 00884883002364 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL2
In Commercial Distribution

  • 00884883002357 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
CAI-XL1
In Commercial Distribution

  • 00884883002340 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-MP
In Commercial Distribution

  • 00884883012004 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-SP
In Commercial Distribution

  • 00884883011991 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-303
In Commercial Distribution

  • 00884883011984 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-202
In Commercial Distribution

  • 00884883011977 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-101
In Commercial Distribution

  • 00884883011960 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-L
In Commercial Distribution

  • 00884883011953 ()


  • Multiple cardiac marker IVD, control
No Description
Microgenics Corporation
OCRD-UL
In Commercial Distribution

  • 00884883011946 ()


  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1066x
In Commercial Distribution

  • 00867556000195 ()


  • Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)
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)
SENSEI, BTE 13 WL 90 BB
Oticon A/S
131225
In Commercial Distribution

  • 05707131255853 ()


  • Air-conduction hearing aid, behind-the-ear
SENSEI, BTE 312 WL 75 BB
Oticon A/S
131203
In Commercial Distribution

  • 05707131255747 ()


  • Air-conduction hearing aid, behind-the-ear
SENSEI PRO, RITE 312 WL BB
Oticon A/S
129844
In Commercial Distribution

  • 05707131255372 ()


  • Air-conduction hearing aid, receiver-in-the-ear
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