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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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On Call Express II Glucose Monitoring System - 00682607571079

Blood Glucose Meter, 10 test strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G117-10A
In Commercial Distribution

  • 00682607001675 ()
  • 10682607571076 ()
  • 00682607571079 ()
  • 20682607571073 ()
757107

  • Glucose monitoring system IVD, home-use

On Call Express Voice Blood Glucose Meter - 00682607571024

Blood Glucose Meter
Acon Laboratories, Inc.
G117-148
In Commercial Distribution

  • 00682607000012 ()
  • 10682607571021 ()
  • 00682607571024 ()
  • 20682607571028 ()
757102

  • Glucose monitoring system IVD, home-use

On Call Express Voice Blood Glucose Monitoring System - 00682607571017

Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G117-108
In Commercial Distribution

  • 00682607000012 ()
  • 10682607571014 ()
  • 00682607571017 ()
  • 20682607571011 ()
757101

  • Glucose monitoring system IVD, home-use

On Call Pro Glucose Control Solution Kit - 00682607558315

Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2
Acon Laboratories, Inc.
G125-12L
In Commercial Distribution

  • 20682607558319 ()
  • 10682607558312 ()
  • 00682607558315 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Pro Blood Glucose Test Strips - 00682607558216

Blood Glucose Test Strips, box of 50 strips
Acon Laboratories, Inc.
G135-10L
In Commercial Distribution

  • 10682607558213 ()
  • 00682607558216 ()
  • 20682607558210 ()
  • 00682607000128 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Pro Blood Glucose Meter - 00682607558186

Blood Glucose Meter
Acon Laboratories, Inc.
G115-11L
In Commercial Distribution

  • 00682607000289 ()
  • 20682607558180 ()
  • 00682607558186 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Vivid Pal Blood Glucose Meter - 00682607558155

Blood Glucose Meter
Acon Laboratories, Inc.
G115-147
In Commercial Distribution

  • 00682607001057 ()
  • 10682607558152 ()
  • 00682607558155 ()
  • 20682607558159 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Vivid Pal Blood Glucose Monitoring System - 00682607558117

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G115-107
In Commercial Distribution

  • 00682607001057 ()
  • 20682607558111 ()
  • 10682607558114 ()
  • 00682607558117 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Express Glucose Control Solution Kit - 00682607557325

Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2
Acon Laboratories, Inc.
G125-12D
In Commercial Distribution

  • 10682607557322 ()
  • 00682607557325 ()
  • 20682607557329 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

On Call Express Blood Glucose Test Strips - 00682607557295

Blood Glucose Test Strips, box of 50 strips
Acon Laboratories, Inc.
G135-10D
In Commercial Distribution

  • 10682607557292 ()
  • 00682607557295 ()
  • 20682607557299 ()
  • 00682607000111 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

On Call Express Blood Glucose Meter - 00682607557165

Blood Glucose Meter
Acon Laboratories, Inc.
G115-11D
In Commercial Distribution

  • 00682607000074 ()
  • 20682607557169 ()
  • 10682607557162 ()
  • 00682607557165 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Express Blood Glucose Monitoring System - 00682607557158

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G115-10D
In Commercial Distribution

  • 00682607000074 ()
  • 10682607557155 ()
  • 00682607557158 ()
  • 20682607557152 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Vivid Glucose Control Solution Kit - 00682607556311

Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2
Acon Laboratories, Inc.
G125-122
In Commercial Distribution

  • 10682607556318 ()
  • 00682607556311 ()
  • 20682607556315 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

On Call Vivid Blood Glucose Test Strips - 00682607556229

Blood Glucose Test Strips, box of 50 strips
Acon Laboratories, Inc.
G135-102
In Commercial Distribution

  • 20682607556223 ()
  • 10682607556226 ()
  • 00682607556229 ()
  • 00682607000050 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

On Call Vivid Blood Glucose Meter - 00682607556151

Blood Glucose Meter
Acon Laboratories, Inc.
G115-142
In Commercial Distribution

  • 00682607000012 ()
  • 10682607556158 ()
  • 00682607556151 ()
  • 20682607556155 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Vivid Blood Glucose Monitoring System - 00682607556113

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G115-102
In Commercial Distribution

  • 00682607000012 ()
  • 20682607556117 ()
  • 10682607556110 ()
  • 00682607556113 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Express Mobile Blood Glucose Meter - 00682607550142

Blood Glucose Meter
Acon Laboratories, Inc.
G115-14S
In Commercial Distribution

  • 00682607001200 ()
  • 10682607550149 ()
  • 00682607550142 ()
  • 20682607550146 ()
755014

  • Glucose monitoring system IVD, home-use

On Call Express Mobile Blood Glucose Monitoring System - 00682607550128

Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G115-10S
In Commercial Distribution

  • 00682607001200 ()
  • 10682607550125 ()
  • 00682607550128 ()
  • 20682607550122 ()
755012

  • Glucose monitoring system IVD, home-use

On Call Plus Blood Glucose Meter - 00682607538157

Blood Glucose Meter
Acon Laboratories, Inc.
G113-217
In Commercial Distribution

  • 00682607000135 ()
  • 20682607538151 ()
  • 00682607538157 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Plus Glucose Control Solution Kit - 00682607535316

Glucose Control Solution Kit includes 2mL Control 1, 2mL Control 2
Acon Laboratories, Inc.
G123-311
In Commercial Distribution

  • 20682607535310 ()
  • 00682607535316 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

On Call Plus Blood Glucose Test Strips - 00682607535217

Blood Glucose Test Strips, box of 50 strips
Acon Laboratories, Inc.
G133-111
In Commercial Distribution

  • 20682607535211 ()
  • 00682607535217 ()
  • 00682607000173 ()


  • Glucose monitoring system IVD, home-use
  • Glucose monitoring system IVD, point-of-care

On Call Plus Blood Glucose Monitoring System - 00682607535118

Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Acon Laboratories, Inc.
G113-111
In Commercial Distribution

  • 00682607000135 ()
  • 20682607535112 ()
  • 00682607535118 ()


  • Glucose monitoring system IVD, point-of-care
  • Glucose monitoring system IVD, home-use

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Mission Liquid Urine Controls - 00682607200702

Liquid Urine Control
Acon Laboratories, Inc.
U021-071
In Commercial Distribution

  • 20682607200706 ()
  • 00682607200702 ()
  • 00682607200696 ()


  • Multiple urine analyte IVD, control

Mission Liquid Urine Controls - 00682607200696

Liquid Urine Control
Acon Laboratories, Inc.
U021-071
In Commercial Distribution

  • 20682607200690 ()
  • 00682607200696 ()


  • Multiple urine analyte IVD, control

Mission Liquid Urine Controls - 00682607200689

Liquid Urine Control
Acon Laboratories, Inc.
U021-011
In Commercial Distribution

  • 20682607200683 ()
  • 00682607200689 ()
  • 00682607200672 ()


  • Multiple urine analyte IVD, control

Mission Liquid Urine Controls - 00682607200672

Liquid Urine Control
Acon Laboratories, Inc.
U021-011
In Commercial Distribution

  • 20682607200676 ()
  • 00682607200672 ()


  • Multiple urine analyte IVD, control

Mission Urinalysis Reagent Strips - 00682607200412

Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
Acon Laboratories, Inc.
U031-111
In Commercial Distribution

  • 20682607200416 ()
  • 00682607200412 ()
  • 00682607001040 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200405

Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
Acon Laboratories, Inc.
U031-101
In Commercial Distribution

  • 20682607200409 ()
  • 00682607200405 ()
  • 00682607001033 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200399

Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
Acon Laboratories, Inc.
U031-091
In Commercial Distribution

  • 20682607200393 ()
  • 00682607200399 ()
  • 00682607001026 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200382

Mission Urinalysis Reagent Strips (PH/GLU/BIL/PRO/URO/NIT/LEU/KET)
Acon Laboratories, Inc.
U031-081
In Commercial Distribution

  • 20682607200386 ()
  • 00682607200382 ()
  • 00682607001019 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200375

Mission Urinalysis Reagent Strips (GLU/SG/BLO/PH/PRO/URO/NIT/LEU)
Acon Laboratories, Inc.
U031-081
In Commercial Distribution

  • 20682607200379 ()
  • 00682607200375 ()
  • 00682607001002 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200368

Mission Urinalysis Reagent Strips (GLU/KET/SG/BLO/PH/PRO/NIT/LEU)
Acon Laboratories, Inc.
U031-081
In Commercial Distribution

  • 20682607200362 ()
  • 00682607200368 ()
  • 00682607000999 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200351

Mission Urinalysis Reagent Strips (GLU/BIL/KET/BLO/PH/PRO/URO/NIT)
Acon Laboratories, Inc.
U031-081
In Commercial Distribution

  • 20682607200355 ()
  • 00682607200351 ()
  • 00682607000982 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200344

Mission Urinalysis Reagent Strips (GLU/KET/PRO/PH/BLO/NIT/LEU)
Acon Laboratories, Inc.
U031-071
In Commercial Distribution

  • 20682607200348 ()
  • 00682607200344 ()
  • 00682607000975 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200337

Mission Urinalysis Reagent Strips (BIL/SG/BLO/URO/PRO/NIT)
Acon Laboratories, Inc.
U031-061
In Commercial Distribution

  • 20682607200331 ()
  • 00682607200337 ()
  • 00682607000968 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200320

Mission Urinalysis Reagent Strips (GLU/PRO/PH/BLO/NIT/LEU)
Acon Laboratories, Inc.
U031-061
In Commercial Distribution

  • 20682607200324 ()
  • 00682607200320 ()
  • 00682607000951 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200313

Mission Urinalysis Reagent Strip (BIL/URO/LEU/NIT/BLO)
Acon Laboratories, Inc.
U031-051
In Commercial Distribution

  • 20682607200317 ()
  • 00682607200313 ()
  • 00682607000944 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200306

Mission Urinalysis Reagent Strip (GLU/SG/PRO/PH/BLO)
Acon Laboratories, Inc.
U031-051
In Commercial Distribution

  • 20682607200300 ()
  • 00682607200306 ()
  • 00682607000937 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

Mission Urinalysis Reagent Strips - 00682607200290

Mission Urinalysis Reagent Strips (GLU/PRO/NIT/BLO/LEU)
Acon Laboratories, Inc.
U031-051
In Commercial Distribution

  • 20682607200294 ()
  • 00682607200290 ()
  • 00682607000920 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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