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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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Fungal Serology - 10634853000169

Normal Rabbit Serum (Negative), 1mL
MICROBIOLOGICS INC.
200155
Not in Commercial Distribution

  • 10634853000169 ()
200155

  • Negative control immunoglobulin IVD

Fungal Serology - 10634853000121

Histoplasma capsulatum Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200260
Not in Commercial Distribution

  • 10634853000121 ()
200260

  • Histoplasma capsulatum exoantigen IVD, control

Fungal Serology - 10634853000114

Histoplasma capsulatum Antiserum (H&M), 2mL
MICROBIOLOGICS INC.
200135
Not in Commercial Distribution

  • 10634853000114 ()
200135

  • Histoplasma capsulatum total antibody IVD, control

Fungal Serology - 10634853000107

Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO
MICROBIOLOGICS INC.
200245
Not in Commercial Distribution

  • 10634853000107 ()
200245

  • Histoplasma capsulatum exoantigen IVD, control

Fungal Serology - 10634853000091

Histoplasma capsulatum Antigen (H&M), 1mL
MICROBIOLOGICS INC.
200120
Not in Commercial Distribution

  • 10634853000091 ()
200120

  • Histoplasma capsulatum antigen IVD, control

Fungal Serology - 10634853000084

Coccidioides immitis Antiserum (HS), ID/EXO
MICROBIOLOGICS INC.
200270
Not in Commercial Distribution

  • 10634853000084 ()
200270

  • Coccidioides immitis exoantigen IVD, control

Fungal Serology - 10634853000077

Coccidioides immitis Antiserum (F), 2mL
MICROBIOLOGICS INC.
200145
Not in Commercial Distribution

  • 10634853000077 ()
200145

  • Coccidioides immitis total antibody IVD, control

Fungal Serology - 10634853000060

Coccidioides immitis Antigen (HS), 2mL ID/EXO
MICROBIOLOGICS INC.
200255
Not in Commercial Distribution

  • 10634853000060 ()
200255

  • Coccidioides immitis exoantigen IVD, control

Fungal Serology - 10634853000053

Coccidioides immitis Antigen (F), 1mL
MICROBIOLOGICS INC.
200130
Not in Commercial Distribution

  • 10634853000053 ()
200130

  • Coccidioides immitis total antibody IVD, control

Fungal Serology - 10634853000046

Blastomyces dermatitidis Antiserum, 2mL
MICROBIOLOGICS INC.
200140
Not in Commercial Distribution

  • 10634853000046 ()
200140

  • Blastomyces dermatitidis total antibody IVD, control

Fungal Serology - 10634853000039

Blastomyces dermatitidis Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200265
Not in Commercial Distribution

  • 10634853000039 ()
200265

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000022

Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000015

Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

MassTrak™ - 00816776020001

Waters® MassTrak™ Immunosuppressants Kit
WATERS TECHNOLOGIES CORPORATION
186002891
In Commercial Distribution

  • 00816776020001 ()
186002891

  • Tacrolimus therapeutic drug monitoring IVD, control
  • Tacrolimus therapeutic drug monitoring IVD, calibrator

USA Elite System - 00821925002074

USA Elite System Continuous Flow Resectoscope Outer Sheath, Raised Tip 25.6 Fr, (8.5 mm) Color Coded Yellow
Gyrus ACMI, LLC
EOS-CFR-25
In Commercial Distribution

  • 00821925002074 ()


  • General-purpose endoscopic needle, reusable

Lymphotype HLA-ABC 120 - 07611969952779

for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823030
Not in Commercial Distribution

  • 07611969952779 ()
823030

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-AB 72 AN - 07611969952731

for 6 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823023
Not in Commercial Distribution

  • 07611969952731 ()
823023

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphostabil - 07611969953073

For conservation of lymphocytes, free of Ca and Mg, not for infusion
Bio-Rad Medical Diagnostics GmbH
824020
Not in Commercial Distribution

  • 07611969953073 ()
824020

  • Cell culture medium IVD

Lymphotype HLA-B27 special - 07611969952908

for 18 detections of human HLA-B27 antigen in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823110
Not in Commercial Distribution

  • 07611969952908 ()
823110

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-DR/DQ 72 - 07611969952885

for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823102
Not in Commercial Distribution

  • 07611969952885 ()
823102

  • HLA class II antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-AB 144 - 07611969952854

for 3 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823070
Not in Commercial Distribution

  • 07611969952854 ()
823070

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-ABC 144 Italia - 07611969952830

for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823045
Not in Commercial Distribution

  • 07611969952830 ()
823045

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-AB 120 special - 07611969952786

for 3 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823031
Not in Commercial Distribution

  • 07611969952786 ()
823031

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

Lymphotype HLA-ABC 72 - 07611969952717

for 6 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823020
Not in Commercial Distribution

  • 07611969952717 ()
823020

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)

ARROW - 00801902098962

Arrow(R) PICC Kit featuring Chlorag+ard(R) Technology with Pressure Injectable, Blue Flex Tip (R) Catheter
TELEFLEX INCORPORATED
IPN032858
In Commercial Distribution

  • 30801902098963 ()
  • 00801902098962 ()
ASK-45552-RWJ3

  • Centrally-inserted central venous catheter

ARROW - 00801902091628

Arrow(R) PICC Kit featuring Chlorag+ard(R) Technology with Pressure Injectable, Blue Flex Tip (R) Catheter
TELEFLEX INCORPORATED
IPN032857
In Commercial Distribution

  • 30801902091629 ()
  • 00801902091628 ()
ASK-45552-RWJ3

  • Centrally-inserted central venous catheter

MicroVue - 30014613335559

MicroVue CIC-C1q Ctrls
QUIDEL CORPORATION
CIC-C1q Controls
In Commercial Distribution

  • 30014613335559 ()
A013

  • Circulating immune complex (CIC) IVD, control

Keratin 5 Polyclonal Chicken Antibody, Purified - 00810034700087

URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-chicken-antibody-purified-10957
BIOLEGEND, INC.
905901
In Commercial Distribution

  • 00810034700087 ()

  • Total Volume: 100 Microliter
905901

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Keratin 5 Polyclonal Antibody, Purified - 00810034700063

URL: https://www.biolegend.com/en-us/products/keratin-5-polyclonal-antibody-purified-10956
BIOLEGEND, INC.
905501
In Commercial Distribution

  • 00810034700063 ()

  • Total Volume: 100 Microliter
905501

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Keratin 14 Polyclonal Antibody, Purified. - 00810034700049

URL: https://www.biolegend.com/en-us/products/keratin-14-polyclonal-antibody-purified-10953
BIOLEGEND, INC.
905301
In Commercial Distribution

  • 00810034700049 ()

  • Total Volume: 100 Microliter
905301

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

Hologic - 15420045506633

Universal General Purpose Reagent - Universal Arm6/Red FRET.
Hologic, Inc.
UNIVERSAL ARM6/RED FRET
Not in Commercial Distribution

  • 15420045506633 ()
96-016

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Hologic - 15420045506619

Universal General Purpose Reagent - Universal Arm4/Red FRET.
Hologic, Inc.
UNIVERSAL ARM4/RED FRET
Not in Commercial Distribution

  • 15420045506619 ()
96-014

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Hologic - 15420045506602

Universal General Purpose Reagent - Universal Arm4/FAM FRET.
Hologic, Inc.
UNIVERSAL ARM4/FAM FRET
Not in Commercial Distribution

  • 15420045506602 ()
96-013

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Hologic - 15420045506596

Universal General Purpose Reagent - Universal Arm3/Red FRET.
Hologic, Inc.
UNIVERSAL ARM3/RED FRET
In Commercial Distribution

  • 15420045506596 ()
96-011

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Hologic - 15420045506572

Universal General Purpose Reagent - Universal Arm1/Red FRET.
Hologic, Inc.
UNIVERSAL ARM1/RED FRET
In Commercial Distribution

  • 15420045506572 ()
96-008

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Vysis - 00884999031647

Vysis LSI BCR/ABL1/ASS1 Tri-Color Dual Fusion Probe (20 uL)
ABBOTT MOLECULAR INC.
08L79-020
In Commercial Distribution

  • 00884999031647 ()
08L79-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999029392

Vysis LSI MYB (6q23) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J86-011
In Commercial Distribution

  • 00884999029392 ()
07J86-011

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999029156

Vysis LSI N-MYC SpectrumGreen/CEP 2 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J72-001
In Commercial Distribution

  • 00884999029156 ()
07J72-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999027091

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J22-050
In Commercial Distribution

  • 00884999027091 ()
07J22-050

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027084

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-012
In Commercial Distribution

  • 00884999027084 ()
07J22-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis - 00884999027077

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-008
In Commercial Distribution

  • 00884999027077 ()
07J22-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027060

ProbeChek Low Level Male 95% XX/5% XY
ABBOTT MOLECULAR INC.
07J21-012
In Commercial Distribution

  • 00884999027060 ()
07J21-012

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027053

ProbeChek Low Level Female 5% XX/95% XY
ABBOTT MOLECULAR INC.
07J21-011
In Commercial Distribution

  • 00884999027053 ()
07J21-011

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027046

ProbeChek Positive Control 10% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-002
In Commercial Distribution

  • 00884999027046 ()
07J21-002

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027039

ProbeChek Negative Control 0% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-001
In Commercial Distribution

  • 00884999027039 ()
07J21-001

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027022

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J20-050
In Commercial Distribution

  • 00884999027022 ()
07J20-050

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027015

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-012
In Commercial Distribution

  • 00884999027015 ()
07J20-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis - 00884999027008

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-008
In Commercial Distribution

  • 00884999027008 ()
07J20-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999026254

Propidium Iodide Counterstain, 2 x 500 uL (400 ng/mL)
ABBOTT MOLECULAR INC.
07J06-001
In Commercial Distribution

  • 00884999026254 ()
07J06-001

  • DAPI solution IVD

Vysis - 00884999021990

Vysis LSI/WCP Hybridization Buffer 2 x 500 uL
ABBOTT MOLECULAR INC.
06J67-011
In Commercial Distribution

  • 00884999021990 ()
06J67-011

  • Nucleic acid hybridization detection IVD, reagent
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