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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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Fort Worth Diagnostics - 00850051429325

Ureaplasma Primer Set
Fort Worth Diagnostics, LLC
UREA002
In Commercial Distribution

  • 00850051429325 ()
UREA002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429318

Mycoplasma Primer Set
Fort Worth Diagnostics, LLC
MYCO002
In Commercial Distribution

  • 00850051429318 ()
MYCO002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429301

Megasphaera Primer Set
Fort Worth Diagnostics, LLC
MEGA002
In Commercial Distribution

  • 00850051429301 ()
MEGA002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429295

Gardnerella vaginalis Primer Set
Fort Worth Diagnostics, LLC
GAR002
In Commercial Distribution

  • 00850051429295 ()
GAR002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429288

Candida spp Primer Set
Fort Worth Diagnostics, LLC
CSPP002
In Commercial Distribution

  • 00850051429288 ()
CSPP002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429271

Candida krusei Primer Set
Fort Worth Diagnostics, LLC
KRU002
In Commercial Distribution

  • 00850051429271 ()
KRU002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429264

Candida glabrata Primer Set
Fort Worth Diagnostics, LLC
GLA002
In Commercial Distribution

  • 00850051429264 ()
GLA002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429257

BVAB2 Primer Set
Fort Worth Diagnostics, LLC
BVAB002
In Commercial Distribution

  • 00850051429257 ()
BVAB002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429240

Atopobium vaginae Primer Set
Fort Worth Diagnostics, LLC
ATO002
In Commercial Distribution

  • 00850051429240 ()
ATO002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429233

Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR002
In Commercial Distribution

  • 00850051429233 ()
BOR002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429226

JCV Primer Set
Fort Worth Diagnostics, LLC
JCV002
In Commercial Distribution

  • 00850051429226 ()
JCV002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429219

RSV Primer Set
Fort Worth Diagnostics, LLC
RSV001
In Commercial Distribution

  • 00850051429219 ()
RSV001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429202

Influenza B Primer Set
Fort Worth Diagnostics, LLC
FLUB001
In Commercial Distribution

  • 00850051429202 ()
FLUB001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429196

Influenza A Primer Set
Fort Worth Diagnostics, LLC
FLUA003
In Commercial Distribution

  • 00850051429196 ()
FLUA003

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429189

Influenza A Primer Set
Fort Worth Diagnostics, LLC
FLUA001
In Commercial Distribution

  • 00850051429189 ()
FLUA001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429172

SARS-CoV-2 Primer Set
Fort Worth Diagnostics, LLC
COV001
In Commercial Distribution

  • 00850051429172 ()
COV001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429158

Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR002
In Commercial Distribution

  • 00850051429158 ()
EHR002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429141

Borrelia miyamotoi Primer Set
Fort Worth Diagnostics, LLC
MIY002
In Commercial Distribution

  • 00850051429141 ()
MIY002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429134

Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB002
Not in Commercial Distribution

  • 00850051429134 ()
BAB002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429127

Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA002
Not in Commercial Distribution

  • 00850051429127 ()
ANA002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429103

HSV-1 Primer Set
Fort Worth Diagnostics, LLC
HSV1002
In Commercial Distribution

  • 00850051429103 ()
HSV1002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429080

Bacillus atrophaeus Primer Set
Fort Worth Diagnostics, LLC
BAT001
In Commercial Distribution

  • 00850051429080 ()
BAT001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429073

Group B Streptococcus Primer Set
Fort Worth Diagnostics, LLC
GBS001
In Commercial Distribution

  • 00850051429073 ()
GBS001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429066

Candida auris Primer Set
Fort Worth Diagnostics, LLC
CAUR002
In Commercial Distribution

  • 00850051429066 ()
CAUR002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429059

Candida auris Primer Set
Fort Worth Diagnostics, LLC
CAUR001
In Commercial Distribution

  • 00850051429059 ()
CAUR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429042

Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR001
In Commercial Distribution

  • 00850051429042 ()
EHR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429035

Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR001
In Commercial Distribution

  • 00850051429035 ()
BOR001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429028

Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA001
In Commercial Distribution

  • 00850051429028 ()
ANA001

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429004

Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB001
In Commercial Distribution

  • 00850051429004 ()
BAB001

  • Assay development analyte-specific reagent IVD

Clostridium difficile (CDF) Amplification Tray - 00857573006317

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).
NANOSPHERE, INC.
20-011-022
Not in Commercial Distribution

  • 00857573006317 ()


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

Gram-Negative Blood Culture (BC-GN) Utility Tray - 00857573006300

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.
NANOSPHERE, INC.
20-011-021
Not in Commercial Distribution

  • 00857573006300 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Respiratory Pathogens Flex (RP Flex) Amplification Tray - 00857573006324

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.
NANOSPHERE, INC.
20-011-024
Not in Commercial Distribution

  • 00857573006324 ()


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

Respiratory Virus Plus (RV+) Amplification Tray - 00857573006294

The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


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

Enteric Pathogens (EP) Amplification Tray - 00857573006089

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.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution

  • 00857573006089 ()


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

HACH - 00851575007365

MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365) that contains 6 individual MONTHLY MAINTENANCE KITs (Model Number 9717300; Primary DI Number 00851575007242)
HACH COMPANY
9756600
In Commercial Distribution

  • 00851575007365 ()
9756600

  • Haemodialysis system chlorine monitor

HACH - 00851575007242

MONTHLY MAINTENANCE KIT, CM130
HACH COMPANY
9717300
In Commercial Distribution

  • 00851575007242 ()
9717300

  • Haemodialysis system chlorine monitor

RTI Allograft Paste - 00854095006993

Allograft Strip IC 90mm
Rti Surgical, Inc.
803190
In Commercial Distribution

  • 00854095006993 ()


  • Bone matrix implant, human-derived

RTI Allograft Paste - 00854095006986

Allograft Strip IC 50mm
Rti Surgical, Inc.
803150
In Commercial Distribution

  • 00854095006986 ()


  • Bone matrix implant, human-derived

RTI Allograft Paste - 00854095006979

Allograft Paste 10cc
Rti Surgical, Inc.
801110
In Commercial Distribution

  • 00854095006979 ()


  • Bone matrix implant, human-derived

RTI Allograft Paste - 00854095006962

Allograft Paste 5cc
Rti Surgical, Inc.
801105
In Commercial Distribution

  • 00854095006962 ()


  • Bone matrix implant, human-derived

RTI Allograft Paste - 00854095006955

Allograft Paste 1cc
Rti Surgical, Inc.
801101
In Commercial Distribution

  • 00854095006955 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006733

DBM Paste
Rti Surgical, Inc.
807891
In Commercial Distribution

  • 00854095006733 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006726

DBM Paste
Rti Surgical, Inc.
807890
In Commercial Distribution

  • 00854095006726 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006719

DBM Paste
Rti Surgical, Inc.
807875
In Commercial Distribution

  • 00854095006719 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006702

DBM Paste
Rti Surgical, Inc.
807845
In Commercial Distribution

  • 00854095006702 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006696

DBM Paste
Rti Surgical, Inc.
807830
In Commercial Distribution

  • 00854095006696 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006689

DBM Paste
Rti Surgical, Inc.
807820
In Commercial Distribution

  • 00854095006689 ()


  • Bone matrix implant, human-derived

BioSet® - 00854095006498

DBM Paste
Rti Surgical, Inc.
008890
In Commercial Distribution

  • 00854095006498 ()
008890

  • Bone matrix implant, human-derived

BioSet® - 00854095006481

DBM Paste
Rti Surgical, Inc.
008850
In Commercial Distribution

  • 00854095006481 ()
008850

  • Bone matrix implant, human-derived

BioSet® - 00854095006474

DBM Paste
Rti Surgical, Inc.
007891
In Commercial Distribution

  • 00854095006474 ()
007891

  • Bone matrix implant, human-derived
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