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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Lyphochek Tumor Marker Plus Control Trilevel MiniPak (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
368X
In Commercial Distribution

  • 00847661003403 ()
368X

  • Multiple tissue-associated protein/tumour marker IVD, control
VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00107
In Commercial Distribution

  • 00847661002581 ()
00107

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00112
In Commercial Distribution

  • 00847661002574 ()
00112

  • Multiple blood-borne virus antigen/antibody IVD, control
VIROCLEAR (An unassayed (human) serological control.)
BIO-RAD LABORATORIES, INC.
00106
In Commercial Distribution

  • 00847661002567 ()
00106

  • Multiple blood-borne virus antigen/antibody IVD, control
Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.)
BIO-RAD LABORATORIES, INC.
745X
In Commercial Distribution

  • 00847661001959 ()
745X

  • Multiple coagulation factor IVD, control
Lyphochek Whole Blood Metals Control Level 3 (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
529
In Commercial Distribution

  • 00847661001706 ()
529

  • Multiple heavy metal IVD, control
Lyphochek Urine Bone Markers Control Bilevel (A human urine bone markers control.)
BIO-RAD LABORATORIES, INC.
406
In Commercial Distribution

  • 00847661001607 ()
406

  • Multiple-type clinical chemistry analyte profile IVD, control
Liquichek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
366
In Commercial Distribution

  • 00847661001577 ()
366

  • Multiple clinical chemistry protein IVD, control
Liquichek Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
365
In Commercial Distribution

  • 00847661001560 ()
365

  • Multiple clinical chemistry protein IVD, control
Liquichek Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
364
In Commercial Distribution

  • 00847661001553 ()
364

  • Multiple clinical chemistry protein IVD, control
Liquichek Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
359
In Commercial Distribution

  • 00847661001546 ()
359

  • Multiple clinical chemistry protein IVD, control
Liquichek Tumor Marker Control Level 3 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
549
In Commercial Distribution

  • 00847661001461 ()
549

  • Multiple tissue-associated protein/tumour marker IVD, control
Liquichek Tumor Marker Control Level 2 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
548
In Commercial Distribution

  • 00847661001454 ()
548

  • Multiple tissue-associated protein/tumour marker IVD, control
Liquichek Tumor Marker Control Level 1 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
547
In Commercial Distribution

  • 00847661001447 ()
547

  • Multiple tissue-associated protein/tumour marker IVD, control
Lyphochek Tumor Marker Plus Control Level 3 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
369
In Commercial Distribution

  • 00847661001430 ()
369

  • Multiple tissue-associated protein/tumour marker IVD, control
Lyphochek Tumor Marker Plus Control Level 2 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
368
In Commercial Distribution

  • 00847661001423 ()
368

  • Multiple tissue-associated protein/tumour marker IVD, control
Lyphochek Tumor Marker Plus Control Level 1 (A human based assayed tumor marker control.)
BIO-RAD LABORATORIES, INC.
367
In Commercial Distribution

  • 00847661001416 ()
367

  • Multiple tissue-associated protein/tumour marker IVD, control
Lyphochek Hypertension Markers Control, Trilevel (A human based assayed hypertension markers control.)
BIO-RAD LABORATORIES, INC.
600
In Commercial Distribution

  • 00847661001065 ()
600

  • Multiple human hormone IVD, control
Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.)
BIO-RAD LABORATORIES, INC.
745
In Commercial Distribution

  • 00847661000785 ()
745

  • Multiple coagulation factor IVD, control
Liquichek Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
148
In Commercial Distribution

  • 00847661000747 ()
148

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
146
In Commercial Distribution

  • 00847661000723 ()
146

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Marker Plus Control LT Level Low (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
149
In Commercial Distribution

  • 00847661000709 ()
149

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level 3 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
648
In Commercial Distribution

  • 00847661000693 ()
648

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level 1 (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
646
In Commercial Distribution

  • 00847661000679 ()
646

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Control LT Level Low (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
649
In Commercial Distribution

  • 00847661000655 ()
649

  • Multiple cardiac marker IVD, control
Liquichek Cardiac Markers Plus Control Trilevel (A human serum assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
180
In Commercial Distribution

  • 00847661000617 ()
180

  • Multiple cardiac marker IVD, control
Liquichek ANA Control, Mitotic Spindle Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
118
In Commercial Distribution

  • 00847661000129 ()
118

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Centromere Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
112
In Commercial Distribution

  • 00847661000112 ()
112

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Nucleolar Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
111
In Commercial Distribution

  • 00847661000105 ()
111

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Speckled Pattern, Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
108
In Commercial Distribution

  • 00847661000099 ()
108

  • Multiple antinuclear antibody (ANA) screening IVD, control
Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum autoimmune control.)
BIO-RAD LABORATORIES, INC.
107
In Commercial Distribution

  • 00847661000082 ()
107

  • Multiple antinuclear antibody (ANA) screening IVD, control
No Description
BIOCARE MEDICAL LLC
NPAI3170T40
In Commercial Distribution

  • 00847627040572 ()


  • CD3 cell marker IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI379T80
In Commercial Distribution

  • 00847627040510 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAI379T40
In Commercial Distribution

  • 00847627040503 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
NPAA3291T80
In Commercial Distribution

  • 00847627040473 ()


  • Helicobacter pylori antigen IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3299AA
In Commercial Distribution

  • 00847627035172 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3299C
In Commercial Distribution

  • 00847627035165 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3299A
In Commercial Distribution

  • 00847627035158 ()


  • Insulinoma-associated protein 1 (INSM1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3296T60
In Commercial Distribution

  • 00847627035097 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3296G7
In Commercial Distribution

  • 00847627035080 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
AVI3296G
In Commercial Distribution

  • 00847627035073 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
API3296AA
In Commercial Distribution

  • 00847627035066 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3296C
In Commercial Distribution

  • 00847627035059 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3296A
In Commercial Distribution

  • 00847627035042 ()


  • CD54 Intercellular adhesion molecule-1 (ICAM-1) IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM405H
In Commercial Distribution

  • 00847627035011 ()


  • GATA protein transcription factor IVD, antibody
No Description
BIOCARE MEDICAL LLC
API438H
In Commercial Distribution

  • 00847627035004 ()


  • Paired box protein (PAX) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ALI3252H
In Commercial Distribution

  • 00847627034991 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3252C
In Commercial Distribution

  • 00847627034984 ()


  • Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
No Description
BIOCARE MEDICAL LLC
PM388H
In Commercial Distribution

  • 00847627034977 ()


  • Napsin A IVD, antibody
No Description
BIOCARE MEDICAL LLC
OPAI3157DS
In Commercial Distribution

  • 00847627034953 ()


  • Multiple solid tumour differentiation marker IVD, antibody
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