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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Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY
RAPID DIAGNOSTICS INC
07RD-7065-39
In Commercial Distribution

  • 00817830022726 ()

  • Length: 75 Millimeter
07RD-7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-11
In Commercial Distribution

  • 00817830022696 ()

  • Length: 75 Millimeter
07RD-7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-II / PCP / THC
RAPID DIAGNOSTICS INC
07RD-7073-01A
In Commercial Distribution

  • 00817830022924 ()

  • Length: 75 Millimeter
07RD-7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-II
RAPID DIAGNOSTICS INC
07RD-7061A
In Commercial Distribution

  • 00817830022917 ()

  • Length: 75 Millimeter
07RD-7061A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520051 ()
NFPMD4335

  • Computed radiography digital imaging scanner
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520044 ()
NF3024C00

  • Computed radiography digital imaging scanner
ACCESSORY OF Maestro Control Panel is a physical keyboard to be used to control Inventis audiometers, through Maestro software while performing audiometric exams.
INVENTIS SRL
MAESTRO CONTROL PANEL
In Commercial Distribution

  • 08054187380914 ()
12080

  • Tone audiometer
No Description
DIASORIN MOLECULAR LLC
EL0950
In Commercial Distribution

  • 10816101022202 ()
EL0950

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control
No Description
Aktina Corp.
51-225
In Commercial Distribution

  • B365512250 ()


  • Indexed-immobilization patient positioning system
The Piccolo® Lipid Panel reagent disc, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® Chemistry analyzer, is intended for the in vitro quantitative determination of total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL), and triglycerides (TRIG) in capillary (fingerstick) lithium heparinized whole blood, venous lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. From these determinations low-density lipoprotein cholesterol (LDL), very low-density lipoprotein cholesterol (VLDL), non-HDL cholesterol, and a total cholesterol/high-density lipoprotein cholesterol ratio (TC/H) are calculated by the analyzer. Lipid measurements are used in the diagnosis and treatment of lipid and lipoprotein disorders, atherosclerosis, various liver and renal diseases, diabetes mellitus, and other diseases involving lipid metabolism or various endocrine disorders. This test is waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the test is considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood (venous or capillary) may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0025
In Commercial Distribution

  • EABA40000251 ()
  • EABA40000250 ()
400-0025

  • Glucose/ketone/lipid profile IVD, reagent
The Piccolo® Electrolyte Panel, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of chloride, potassium, sodium, and total carbon dioxide in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The tests on this panel are waived under CLIA ’88 regulations. If a laboratory modifies the test system instructions, then the tests are considered high complexity and subject to all CLIA requirements. For CLIA waived labs, only lithium heparin whole blood may be tested. For use in moderate complexity labs, lithium heparinized whole blood, lithium heparinized plasma, or serum may be used.
ABAXIS, INC.
400-0022
In Commercial Distribution

  • EABA40000221 ()
  • EABA40000220 ()
400-0022

  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
Pregnancy Panel Insert - 0.5mm Regular Lead
Shielding International Inc.
PPIRL
In Commercial Distribution

  • G031PPIRL0 ()


  • Radiation shielding apron
No Description
MAZOR ROBOTICS LTD
MAS1891-06S
In Commercial Distribution

  • 07290115751581 ()


  • Stereotactic surgery system probe, reusable
No Description
MAZOR ROBOTICS LTD
MAS1891-04
Not in Commercial Distribution

  • 07290109182063 ()
MAS1891-04S

  • Stereotactic surgery system probe, reusable
AQUIOS Tetra-2+ Panel CD45-FITC/(CD56 + CD16)-RD1/CD19-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23534
In Commercial Distribution

  • 15099590225735 ()
B23534

  • Multiple CD cell marker IVD, antibody
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801823 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801809 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801793 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801779 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801755 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801731 ()


  • Methadone IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801717 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801816 ()


  • Benzodiazepine group IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801786 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801762 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801748 ()


  • Amphetamine-specific IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801724 ()


  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801700 ()


  • Barbiturate IVD, kit, rapid ICT, clinical
AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5
BECKMAN COULTER IRELAND INC.
B23533
In Commercial Distribution

  • 15099590225704 ()
B23533

  • Multiple CD cell marker IVD, antibody
6PLUS1® Multilevel Serum Calibrator Set MassChrom® Steroid Panel 1 and Panel 2
Chromsystems Instruments + Chemicals GmbH
72040
In Commercial Distribution

  • 04250317539717 ()

  • Total Volume: 3 Milliliter
  • 7 Vials
72040

  • Multiple steroid hormone IVD, calibrator
Wall mount 12 o'clock rear delivery dual purpose
Engle Dental Systems, LLC
P070900
In Commercial Distribution

  • 00850043433033 ()
P070900

  • Dental delivery system instrument unit, pneumatic
Under cabinet top mount 12 o'clock rear delivery (assistant's instruments only)
Engle Dental Systems, LLC
P071460
In Commercial Distribution

  • 00850043433026 ()
P071460

  • Dental delivery system instrument unit, pneumatic
Under cabinet side mount 12 o'clock rear delivery
Engle Dental Systems, LLC
P071450
In Commercial Distribution

  • 00850043433019 ()
P071450

  • Dental delivery system instrument unit, pneumatic
Under cabinet top mount 12 o'clock rear delivery
Engle Dental Systems, LLC
P071438
In Commercial Distribution

  • 00850043433002 ()
P071438

  • Dental delivery system instrument unit, pneumatic
Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM # MAK-1310). Zoral System is attached to the dental unit's quick disconnect air to pressurize the Zoral System.
Anodia Systems
00854542008372
In Commercial Distribution

  • 00854542008211 ()
item # MAK-1310

  • Dental delivery system instrument unit, pneumatic
Under cabinet side mount 12 o'clock rear delivery (assistant's instruments only)
Engle Dental Systems, LLC
P071470
In Commercial Distribution

  • 00850043433507 ()
P071470

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible delivery system with E2 control head
Engle Dental Systems, LLC
P070941
In Commercial Distribution

  • 00850043433484 ()
P070941

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with cuspidor
Engle Dental Systems, LLC
P069240
In Commercial Distribution

  • 00850043433477 ()
P069240

  • Dental delivery system instrument unit, pneumatic
Chair mounted utility center with telescopic arm
Engle Dental Systems, LLC
P069201
In Commercial Distribution

  • 00850043433460 ()
P069201

  • Dental delivery system instrument unit, pneumatic
Chair mounted left / right convertible cuspidor with assistant's group
Engle Dental Systems, LLC
P069265
In Commercial Distribution

  • 00850043433453 ()
P069265

  • Dental delivery system instrument unit, pneumatic
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