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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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Nexplant - 08800024913667

Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210M
In Commercial Distribution

  • 08800024913667 ()
I3210M

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913650

Fixture Φ3.2/L8.0
Achimhai Medical Corporation
I3208M
In Commercial Distribution

  • 08800024913650 ()
I3208M

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913643

Fixture Φ3.2/L14.5
Achimhai Medical Corporation
I3215
In Commercial Distribution

  • 08800024913643 ()
I3215

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913612

Fixture Φ3.2/L9.5
Achimhai Medical Corporation
I3210
In Commercial Distribution

  • 08800024913612 ()
I3210

  • Screw endosteal dental implant, two-piece

Nexplant - 08800024913605

Fixture Φ3.2/L8.0
Achimhai Medical Corporation
I3208
In Commercial Distribution

  • 08800024913605 ()
I3208

  • Screw endosteal dental implant, two-piece

KISSES MINI Internal Fixture - 08800024912585

Kisses Mini Internal Fixture Φ3.2/L9.5
Achimhai Medical Corporation
MFX-3210S
In Commercial Distribution

  • 08800024912585 ()
MFX-3210S-A

  • Screw endosteal dental implant, two-piece

KISSES MINI Internal Fixture - 08800024912547

Kisses Mini Internal Fixture Φ3.2/L8.0
Achimhai Medical Corporation
MFX-3208SD
In Commercial Distribution

  • 08800024912547 ()
MFX-3208SD-A

  • Screw endosteal dental implant, two-piece

KISSES MINI Internal Fixture - 08800024912509

Kisses Mini Internal Fixture Φ3.2/L14.5
Achimhai Medical Corporation
MFX-3215SD
In Commercial Distribution

  • 08800024912509 ()
MFX-3215SD-A

  • Screw endosteal dental implant, two-piece

Respiratory Pathogens Flex (RP Flex) Amplification Tray - 00840487101711

The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
LUMINEX CORPORATION
20-011-024
In Commercial Distribution

20-011-024

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

Clostridium difficile (CDF) Amplification Tray - 00840487101704

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
LUMINEX CORPORATION
20-011-022
In Commercial Distribution

20-011-022

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Gram-Negative Blood Culture (BC-GN) Utility Tray - 00840487101698

The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers.
LUMINEX CORPORATION
20-011-021
In Commercial Distribution

20-011-021

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

Enteric Pathogens (EP) Amplification Tray - 00840487101544

The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
In Commercial Distribution

20-011-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

VITROS - 10758750034642

VITROS Immunodiagnostic Products CK-MB Calibrators
ORTHO CLINICAL DIAGNOSTICS
6199329
In Commercial Distribution

  • 10758750034642 ()
  • 20758750034649 ()
6199329

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034581

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators
ORTHO-CLINICAL DIAGNOSTICS, INC.
6199976
In Commercial Distribution

  • 10758750034581 ()
6199976

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750034420

VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator
ORTHO CLINICAL DIAGNOSTICS
6199961
In Commercial Distribution

  • 10758750034420 ()
6199961

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

i-STAT - 00054749004973

I-STAT TBI Control L2
ABBOTT POINT OF CARE INC.
06P17-26
In Commercial Distribution

  • 00054749004973 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT - 00054749004966

I-STAT TBI Control L1
ABBOTT POINT OF CARE INC.
06P17-25
In Commercial Distribution

  • 00054749004966 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT - 00054749004959

I-STAT TBI Calibration Verification Set
ABBOTT POINT OF CARE INC.
06P17-24
In Commercial Distribution

  • 00054749004959 ()


  • Multiple traumatic brain injury marker IVD, control

i-STAT hs-TnI Control Level 3 - 00054749004942

i-STAT hs-TnI Control Level 3
Abbott Point of Care Inc.
06P17-23
In Commercial Distribution

  • 00054749004942 ()
06P17-23

  • Troponin I IVD, control

i-STAT hs-TnI Control Level 2 - 00054749004935

i-STAT hs-TnI Control Level 2
Abbott Point of Care Inc.
06P17-22
In Commercial Distribution

  • 00054749004935 ()
06P17-22

  • Troponin I IVD, control

i-STAT hs-TnI Control Level 1 - 00054749004928

i-STAT hs-TnI Control Level 1
Abbott Point of Care Inc.
06P17-21
In Commercial Distribution

  • 00054749004928 ()
06P17-21

  • Troponin I IVD, control

i-STAT hs-TnI Calibration Verification, Levels 1-3 - 00054749004911

i-STAT hs-TnI Calibration Verification, Levels 1-3
Abbott Point of Care Inc.
06P17-20
In Commercial Distribution

  • 00054749004911 ()
06P17-20

  • Troponin I IVD, control

VITROS - 10758750002511

VITROS Immunodiagnostic Products Troponin I ES Calibrators
ORTHO CLINICAL DIAGNOSTICS
6802302
In Commercial Distribution

  • 10758750002511 ()
  • 20758750002518 ()
6802302

  • Troponin I IVD, kit, chemiluminescent immunoassay

Liofilchem Mic Test Strip (MTS) - 08055182873357

MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftazidime-Avibactam 0.016/4-256/4 10 Stripsµg/mL
In Commercial Distribution

  • 18055182873354 ()
  • 08055182873357 ()
  • 08055182873333 ()
$92139-10

  • Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD

Liofilchem Mic Test Strip (MTS) - 08055182873340

MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftazidime-avibactam 0.016/4 – 256 /4 µg/mL are specialized strips impregnated with a predefined concentration gradient of Ceftazidime and Avibactam for susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia Coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftazidime-Avibactam 0.016/4-256/4 µg/mL 1 Strip
In Commercial Distribution

  • 28055182873344 ()
  • 08055182873340 ()
  • 18055182873347 ()
$92139-1

  • Ceftazidime/avibactam minimum inhibitory concentration (MIC) IVD

Liofilchem Mic Test Strip (MTS) - 08055182872381

No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 1 Strip
In Commercial Distribution

  • 18055182872388 ()
  • 08055182872381 ()
  • 28055182872385 ()
$92071-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem Mic Test Strip (MTS) - 08055182872305

No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml 10 Strip
In Commercial Distribution

  • 18055182872302 ()
  • 08055182872305 ()
  • 08055182872282 ()
$92068-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182872299

No Description
LIOFILCHEM SRL
Imipenem IMI 0.016-256 µg/ml, 1 Strip
In Commercial Distribution

  • 28055182872293 ()
  • 08055182872299 ()
  • 18055182872296 ()
$92068-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870325

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 10 strips
In Commercial Distribution

  • 18055182870322 ()
  • 08055182870325 ()
  • 08055182870301 ()
$92074-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870103

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 1 strip
In Commercial Distribution

  • 28055182870107 ()
  • 08055182870103 ()
  • 18055182870100 ()
$92084-1

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870080

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 10 strips
In Commercial Distribution

  • 18055182870087 ()
  • 08055182870080 ()
  • 08055182870066 ()
$92146-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem Mic Test Strip (MTS) - 08055182872398

No Description
LIOFILCHEM SRL
Omadacycline 0.002-32 µg/mL, 10 Strip
In Commercial Distribution

  • 18055182872395 ()
  • 08055182872398 ()
  • 08055182872374 ()
$92071-10

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870318

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem-vaborbactam M/V 0.016/8 - 256/8 are specialized strips impregnated with a predefined concentration gradient of Meropenem-vaborbactam for susceptibility testing of Enterobacter cloacae species complex, Escherichia coli, Klebsiella pneumoniae
LIOFILCHEM SRL
Meropenem-vaborbactam M/V 0.016/8 - 256/8 - 1 strip
In Commercial Distribution

  • 28055182870312 ()
  • 08055182870318 ()
  • 18055182870315 ()
$92074-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

Liofilchem MIC Test Strip (MTS) - 08055182870110

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Meropenem 0.002-32 μg/mL are porous strips impregnated with a predefined concentration gradient of meropenem for susceptibility testing of E. coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Meropenem 0.002-32 μg/mL 10 strip
In Commercial Distribution

  • 18055182870117 ()
  • 08055182870110 ()
  • 08055182870097 ()
$92084-10

  • Meropenem minimum inhibitory concentration (MIC) IVD

Liofilchem MIC Test Strip (MTS) - 08055182870073

MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Ceftolozane/Tazobactam 0.016/4 – 256/4 μg/mL are specialized strips impregnated with a predefined concentration gradient of ceftolozane/tazobactam for susceptibility testing of Enterobacter cloacae, E. coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa
LIOFILCHEM SRL
Ceftolozane/Tazobactam 0.016/4 – 256/4 µg/mL 1 strip
In Commercial Distribution

  • 28055182870077 ()
  • 08055182870073 ()
  • 18055182870070 ()
$92146-1

  • Multiple antibacterial minimum inhibitory concentration (MIC) IVD, kit

InteliQ - 03610522354665

InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019558
In Commercial Distribution

  • 03610522354665 ()
12019558

  • Multiple clinical chemistry protein IVD, control

Liquichek - 03610522354658

Liquichek Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay control.)
BIO-RAD LABORATORIES, INC.
12019576
In Commercial Distribution

  • 03610522354658 ()
12019576

  • Multiple clinical chemistry protein IVD, control

Exact Diagnostics - 03610522350773

Bulk CSF Negative
EXACT DIAGNOSTICS, LLC
12019432
In Commercial Distribution

  • 03610522350773 ()
12019432

  • PCR/NAT negative control IVD

InteliQ - 03610522248902

InteliQ Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016487
In Commercial Distribution

  • 03610522248902 ()
12016487

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248896

InteliQ Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016486
In Commercial Distribution

  • 03610522248896 ()
12016486

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248889

InteliQ Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016485
In Commercial Distribution

  • 03610522248889 ()
12016485

  • Multiple cardiac marker IVD, control

InteliQ - 03610522248872

InteliQ Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016484
In Commercial Distribution

  • 03610522248872 ()
12016484

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248698

Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016475
In Commercial Distribution

  • 03610522248698 ()
12016475

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248681

Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016474
In Commercial Distribution

  • 03610522248681 ()
12016474

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248674

Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016473
In Commercial Distribution

  • 03610522248674 ()
12016473

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248667

Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016472
In Commercial Distribution

  • 03610522248667 ()
12016472

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248407

Liquichek Cardiac Advance Control Level 4 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016450
In Commercial Distribution

  • 03610522248407 ()
12016450

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248391

Liquichek Cardiac Advance Control Level 3 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016449
In Commercial Distribution

  • 03610522248391 ()
12016449

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248384

Liquichek Cardiac Advance Control Level 2 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016448
In Commercial Distribution

  • 03610522248384 ()

  • 6 x 3 ml
12016448

  • Multiple cardiac marker IVD, control

Liquichek - 03610522248377

Liquichek Cardiac Advance Control Level 1 (A human based assayed cardiac markers control.)
BIO-RAD LABORATORIES, INC.
12016447
In Commercial Distribution

  • 03610522248377 ()
12016447

  • Multiple cardiac marker IVD, control
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