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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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Healgen - 00816490020431

5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-254A3
In Commercial Distribution

  • 20816490020435 ()
  • 10816490020438 ()
  • 00816490020431 ()
HDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490022480

12 Panel DOA Test Dipcard;+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-6125A3
In Commercial Distribution

  • 20816490022484 ()
  • 10816490022487 ()
  • 00816490022480 ()
HDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490021889

10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-1104A3
In Commercial Distribution

  • 20816490021883 ()
  • 10816490021886 ()
  • 00816490021889 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490021643

10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-4104A3
In Commercial Distribution

  • 20816490021647 ()
  • 10816490021640 ()
  • 00816490021643 ()
HDOA-4104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490021544

10 Panel DOA Test Dipcard+Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-7104A3
In Commercial Distribution

  • 20816490021548 ()
  • 10816490021541 ()
  • 00816490021544 ()
HDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490020493

5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-654A3
In Commercial Distribution

  • 20816490020497 ()
  • 10816490020490 ()
  • 00816490020493 ()
HDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Healgen - 00816490020417

5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QC Sets and Panels: Helix Elite™ - 80845357043708

QC Sets and Panels: Helix Elite™ SARS-CoV-2 Verification Panel
MICROBIOLOGICS INC.
ABT-001
In Commercial Distribution

  • 80845357043708 ()
ABT-001

  • SARS-CoV-2 nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041325

QC Sets and Panels: Helix Elite™ Vaginal Control Panel
MICROBIOLOGICS INC.
8209
In Commercial Distribution

  • 70845357041325 ()
8209

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041318

QC Sets and Panels: Helix Elite™ Vaginal Verification Panel
MICROBIOLOGICS INC.
8208
In Commercial Distribution

  • 70845357041318 ()
8208

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control

QC Sets and Panels: KWIK-STIK™ 2 Pack - 70845357039940

QC Sets and Panels: KWIK-STIK™ Gram Positive Identification Panel
MICROBIOLOGICS INC.
5248P
In Commercial Distribution

  • 70845357039940 ()
5248P

  • Multiple bacteria species culture isolate identification control IVD, kit

QC Sets and Panels: KWIK-STIK™ 2 Pack - 70845357039933

QC Sets and Panels: KWIK-STIK™ Gram Negative Identification Panel
MICROBIOLOGICS INC.
5247P
In Commercial Distribution

  • 70845357039933 ()
5247P

  • Multiple bacteria species culture isolate identification control IVD, kit

Inspiration 7i Ventilator System - B079EVM11000103US0

Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000103US0 ()
F7300000-7i-F-US

  • General-purpose intensive-care ventilator

BAUM - 00810010923547

Mylar Clad Cartridge Tube for Desk, Panel & Wall Unit 33
W. A. BAUM CO., INC.
2300
In Commercial Distribution

  • 00810010923547 ()
2300

  • Aneroid manual sphygmomanometer

HarmonyAIR - 00724995165741

The Dual M5 without Control with two Flat Panel Control, with two Flat Panel Monitors is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165741 ()
LM03N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light

S-N2 CAN-Bus - J021302850021

Foot Control CAN-Bus
W & H Dentalwerk Bürmoos GmbH
30285002
In Commercial Distribution

  • J021302850020 ()
  • J021302850021 ()


  • Foot-switch, electrical
  • Dental delivery system instrument unit, electric

Heparin/PF4 Antibody Serum Panel - 00708872000011

The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
AKERS BIOSCIENCES, INC.
4036028
In Commercial Distribution

  • 00708872000011 ()
  • 01708872000011 ()
4036028

  • Platelet factor 4-heparin complex antibody IVD, control

Heparin/PF4 Antibody Serum Panel - 00708872000004

The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
AKERS BIOSCIENCES, INC.
4036027
In Commercial Distribution

  • 00708872000004 ()
  • 01708872000004 ()
4036027

  • Platelet factor 4-heparin complex antibody IVD, control

PCE Pen Panel Transmitter Box - 00856181003411

The NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
41
In Commercial Distribution

  • 00856181003411 ()


  • Headphones

Hypercoagulation Panel (HC) Sample Buffer - 00857573006348

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution

  • 00857573006348 ()


  • Multiple coagulation factor IVD, kit, clotting

CHECK UP AMERICAL CHOLESTEROL PANEL - M769CHOLESTEROL811

Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Home Access Health Corporation
81
In Commercial Distribution

  • M769CHOLESTEROL811 ()


  • Capillary blood collection set, home-use

CHECK UP AMERICA CHOLESTEROL PANEL - M769CHOLESTEROL801

Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Home Access Health Corporation
80
In Commercial Distribution

  • M769CHOLESTEROL801 ()


  • Capillary blood collection set, home-use

BioFire JI Control Panel M420 - 00852720008121

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control

FilmArray BCID2 Control Panel M416 - 00852720008077

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the BioFire Blood Culture Identification 2 (BCID2) Panel on the FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008077 ()
M416

  • Multiple-type bloodstream pathogen nucleic acid IVD, control

Xpert BCR-ABL IS Panel C130 - 00852720008060

Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008060 ()
C130

  • Philadelphia chromosome/BCR-ABL transcript IVD, control

FilmArray Warrior Control Panel M290 - 00852720008053

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray® NGDS Warrior Panel performed on FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008053 ()
M290

  • Multiple-type bloodstream pathogen nucleic acid IVD, control

FilmArray RP2/RP2plus Control Panel - 00852720008039

External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray RP2 and RP2plus assay on the FilmArray 2.0/Torch systems.
Mmqci
v.00
Not in Commercial Distribution

  • 00852720008039 ()
M315

  • Multiple-genus respiratory virus nucleic acid IVD, control

INTROL CF Panel I Control - 00852720008015

This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008015 ()
G106ac

  • Cystic fibrosis IVD, control

INTROL CF Panel I Control - 00852720008008

This independent CF control is intended for in vitro diagnostic use to monitor the entire testing process of diagnostic assays used in the detection of the CFTR gene mutations and variants.
Mmqci
v.02
In Commercial Distribution

  • 00852720008008 ()
G106ac-1

  • Cystic fibrosis IVD, control

Gastrointestinal Pathogen Panel (GPP) Kit - 00851034007011

In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FILMARRAY NGDS WARRIOR PANEL - CA - 00851458005266

FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution

  • 00851458005266 ()
DFA2-ASY-0012

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Global Fever Panel - 00851458005242

BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
BIOFIRE DEFENSE, LLC
DFA2-ASY-0004
In Commercial Distribution

  • 00851458005242 ()
DFA2-ASY-0004

  • Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® NGDS Warrior Panel - 00851458005136

FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0007
In Commercial Distribution

  • 00851458005136 ()
NGDS-ASY-0007

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

AeroWrap Extension Panel Large/XLarge - 00850051939299

An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6354
In Commercial Distribution

  • 00850051939299 ()
AW-EXT-LB

  • Sequential venous compression system

AeroWrap Extension Panel small/medium - 00850051939282

An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6154
In Commercial Distribution

  • 00850051939282 ()
AW-EXT-SB

  • Sequential venous compression system

9 Panel Drug Test Cup - 10817038022273

9 Panel Drug Test Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
UCP BIOSCIENCES, INC.
U-CUP-794
In Commercial Distribution

  • 20817038022270 ()
  • 10817038022273 ()
  • 00817038022276 ()
U-CUP-794

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

10 Panel Drug Test Cup - 10817038022259

10 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-13104
In Commercial Distribution

  • 00817038022252 ()
  • 10817038022259 ()
  • 20817038022256 ()
U-CUP-13104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

6 Panel Drug Test Cup - 10817038022075

6 Panel Drug Test Cup AMP/BUP/BZO/COC/MOP/OXY with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-CUP-2064-3AD
In Commercial Distribution

  • 20817038022072 ()
  • 10817038022075 ()
  • 00817038022078 ()
U-CUP-2064-3AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Hypercoagulation Panel (HC) Sample Buffer - 00840487101728

The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
Not in Commercial Distribution

30-001-001

  • Multiple coagulation factor IVD, kit, clotting

NxTAG® Respiratory Pathogen Panel - 00840487100417

The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Luminex Molecular Diagnostics, Inc
I051C0447
In Commercial Distribution

  • 00840487100417 ()
I051C0447

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Freelite® Panel Sample Set - 05051700002059

No Description
THE BINDING SITE GROUP LIMITED
BP228
In Commercial Distribution

  • 05051700002059 ()


  • Kappa/lambda light chain immunoglobulin IVD, control

Lipid Panel, 15ct., CCPlus Home - 00381934753010

CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4753
In Commercial Distribution

  • 10381934753017 ()
  • 00381934753010 ()
REF 4753

  • Multiple lipid analyte IVD, kit, spectrophotometry

Selux AST Gram Negative Panel - 00850031114029

No Description
Selux Diagnostics, Inc.
01-80001
In Commercial Distribution

  • 10850031114026 ()
  • 00850031114029 ()


  • Antimicrobial susceptibility analyser IVD

QIAstat-Dx® Respiratory Panel Mini - 04053228048862

No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228048862 ()
691218

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

QIAstat-Dx® Respiratory Panel Plus - 04053228047438

No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228047438 ()
691224

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

Piccolo Basic Metabolic Panel Plus - EABA40000311

The Piccolo® Basic Metabolic Panel Plus, used with the Piccolo blood chemistry analyzer or Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of calcium, chloride, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total carbon dioxide, and blood urea nitrogen in a clinical laboratory setting or point-of-care location. This disc is for testing heparinized plasma and serum, only.
ABAXIS, INC.
400-0031
In Commercial Distribution

  • EABA40000311 ()
  • EABA40000310 ()
400-0031

  • Total lactate dehydrogenase (LDH) IVD, reagent
  • Magnesium (Mg2+) IVD, reagent
  • Chloride (Cl-) IVD, reagent
  • Sodium (Na+) IVD, control
  • Bicarbonate (HCO3-) IVD, reagent
  • Potassium (K+) IVD, reagent
  • Calcium (Ca2+) IVD, reagent
  • Urea IVD, reagent
  • Creatinine IVD, reagent
  • Glucose IVD, reagent

SPOTCHEM™ II Lipid Panel - 00015482771232

Strip description for the invitro quantitative determination of HDL-cholesterol, total cholesterol, and triglyceride in human plasma from whole blood samples
ARKRAY USA, INC.
77123
Not in Commercial Distribution

  • 00015482771232 ()
  • 50015482771237 ()


  • Magnesium (Mg2+) IVD, kit, spectrophotometry

MP DOA-4 PANEL TEST CUP - 00817830022818

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

BioFire® Respiratory Panel 2.1 - 00815381020529

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423742
In Commercial Distribution

  • 00815381020529 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Respiratory Panel (RP) - 00815381020079

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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