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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Liquichek Cardiac Markers Control LT Level 2 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
647
In Commercial Distribution

  • 00847661000686 ()
647

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
645
In Commercial Distribution

  • 00847661000662 ()
645

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
183
In Commercial Distribution

  • 00847661000648 ()
183

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
181
In Commercial Distribution

  • 00847661000624 ()
181

  • Multiple cardiac marker IVD, control
Lyphochek Benzo/TCA Control- Set B Level 2 (A human serum assayed benzodiazepines and TCA control.)
BIO-RAD LABORATORIES, INC.
664
In Commercial Distribution

  • 00847661000600 ()
664

  • Benzodiazepine group IVD, control
  • Tricyclic antidepressant IVD, control
Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA control.)
BIO-RAD LABORATORIES, INC.
663
In Commercial Distribution

  • 00847661000594 ()
663

  • Benzodiazepine group IVD, control
  • Tricyclic antidepressant IVD, control
Lyphochek Benzo/TCA Control- Set A Level 2 (A human serum assayed benzodiazepines and TCA control.)
BIO-RAD LABORATORIES, INC.
662
In Commercial Distribution

  • 00847661000587 ()
662

  • Benzodiazepine group IVD, control
  • Tricyclic antidepressant IVD, control
Lyphochek Benzo/TCA Control- Set A Level 1 (A human serum assayed benzodiazepines and TCA control.)
BIO-RAD LABORATORIES, INC.
661
In Commercial Distribution

  • 00847661000570 ()
661

  • Tricyclic antidepressant IVD, control
  • Benzodiazepine group IVD, control
Lyphochek Urine Metals Control Level 2 (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
405
In Commercial Distribution

  • 00847661000297 ()
405

  • Multiple heavy metal IVD, control
Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.)
BIO-RAD LABORATORIES, INC.
400
In Commercial Distribution

  • 00847661000280 ()
400

  • Multiple heavy metal IVD, control
Liquichek Autoimmune Negative Control (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
130
In Commercial Distribution

  • 00847661000228 ()
130

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Controls Set, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
131
In Commercial Distribution

  • 00847661000211 ()
131

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek Anti-Smooth Muscle Control, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
129
In Commercial Distribution

  • 00847661000204 ()
129

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek Anti-Mitochondrial Control, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
127
In Commercial Distribution

  • 00847661000198 ()
127

  • Mitochondrial antibody M2 (anti-Mi2) IVD, control
No Description
BIOCARE MEDICAL LLC
NPAA3291T40
In Commercial Distribution

  • 00847627040466 ()


  • Helicobacter pylori antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM110L
In Commercial Distribution

  • 00847627040213 ()


  • CD3 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI092T40
In Commercial Distribution

  • 00847627039866 ()


  • Calretinin protein IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI352T40
In Commercial Distribution

  • 00847627039828 ()


  • MUM1 transcription factor IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI390T40
In Commercial Distribution

  • 00847627039804 ()


  • Tissue prostate specific antigen (PSA) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPRI10028T40
In Commercial Distribution

  • 00847627039781 ()


  • Multiple solid tumour differentiation marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI353T40
In Commercial Distribution

  • 00847627039644 ()


  • CD163 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI3058T40
In Commercial Distribution

  • 00847627039620 ()


  • Arginase IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI3181T80
In Commercial Distribution

  • 00847627039590 ()


  • Multiple solid tumour differentiation marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI396T40
In Commercial Distribution

  • 00847627039583 ()


  • Glypican-3 IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI388T80
In Commercial Distribution

  • 00847627039316 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI388T40
In Commercial Distribution

  • 00847627039309 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI266T40
In Commercial Distribution

  • 00847627039286 ()


  • D2-40 antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI3181T40
In Commercial Distribution

  • 00847627039279 ()


  • Multiple solid tumour differentiation marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI3008T40
In Commercial Distribution

  • 00847627039255 ()


  • Delta-catenin IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI403T40
In Commercial Distribution

  • 00847627039170 ()


  • Epithelial cell adhesion molecule (EpCAM) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI392T40
In Commercial Distribution

  • 00847627039156 ()


  • CD99 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI3110T40
In Commercial Distribution

  • 00847627039057 ()


  • CD71 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAA301T80
In Commercial Distribution

  • 00847627039026 ()


  • Estrogen (oestrogen)/progesterone receptor IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAA301T40
In Commercial Distribution

  • 00847627039019 ()


  • Estrogen (oestrogen)/progesterone receptor IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI344T80
In Commercial Distribution

  • 00847627038876 ()


  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI344T40
In Commercial Distribution

  • 00847627038869 ()


  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
Defibrillator ,MAIN, R SERIES, BLS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2/ETCO2/NIBP, CF/STD, DMST
Zoll Medical Corporation
30001005201330013
In Commercial Distribution

  • 00847946017552 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2/ETCO2/NIBP, CF/STD, DMST
Zoll Medical Corporation
30001005201330012
In Commercial Distribution

  • 00847946017545 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN,MAN-1,PLUS,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBPCF/USB,R SERIES,DMST
Zoll Medical Corporation
30001005201310013
In Commercial Distribution

  • 00847946017538 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN,ALS,MAN-1,3/5 LD,STD ECG,AC PWR,SPO2,ETCO2,PACE,NIBP,CF/USB,R SERIES,DMST
Zoll Medical Corporation
30001005201310012
In Commercial Distribution

  • 00847946017521 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, ALS, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, NIBP, CF/USB, DMST
Zoll Medical Corporation
30001005201310011
In Commercial Distribution

  • 00847946017514 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, SPO2/ETOC2/NIBP, CF/STD, DMST
Zoll Medical Corporation
30001005201230013
In Commercial Distribution

  • 00847946017507 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, SPO2, ETCO2, NIBP, CF/STD, DMST
Zoll Medical Corporation
30001005201230012
In Commercial Distribution

  • 00847946017491 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, R SERIES, PLUS, 3/5 LD, STD ECG, AC PWR, SPO2, NIBP, CF/USB, DMST
Zoll Medical Corporation
30001005201210013
In Commercial Distribution

  • 00847946017484 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, R SERIES, ALS, 3/5 LD, STD ECG, AC PWR, SPO2, NIBP, CF/USB, DMST
Zoll Medical Corporation
30001005201210012
In Commercial Distribution

  • 00847946017477 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,R SERIES, MAIN, ALS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/STD, DMST
Zoll Medical Corporation
30001000301130012
In Commercial Distribution

  • 00847946017224 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,R SERIES, MAIN, PLUS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST
Zoll Medical Corporation
30001000301110013
In Commercial Distribution

  • 00847946017217 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,R SERIES, MAIN, ALS, 3/5 LD, AC PWR, STD ECG, PACE, ETCO2, CF/USB, DMST
Zoll Medical Corporation
30001000301110012
In Commercial Distribution

  • 00847946017200 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
Defibrillator ,MAIN, MAN-1, BLS, 3/5 LD, STD ECG, AC PWR, W/PACE, CF/USB, DOMESTIC
Zoll Medical Corporation
30001000001130013
In Commercial Distribution

  • 00847946017194 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
BONE MARROW BIOPSY ASPIRATION
MEDLINE INDUSTRIES, INC.
DYNDH1514
In Commercial Distribution

  • 20193489194019 ()
  • 10193489194012 ()
DYNDH1514

  • Bone marrow biopsy procedure kit
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