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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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HHV-6B Primer Set
Fort Worth Diagnostics, LLC
HHV6B002
In Commercial Distribution

  • 00850051429431 ()
HHV6B002

  • Assay development analyte-specific reagent IVD
HHV-6A Primer Set
Fort Worth Diagnostics, LLC
HHV6A002
In Commercial Distribution

  • 00850051429424 ()
HHV6A002

  • Assay development analyte-specific reagent IVD
HPV Genotype 52 Primer Set
Fort Worth Diagnostics, LLC
HPV52002
In Commercial Distribution

  • 00850051429417 ()
HPV52002

  • Assay development analyte-specific reagent IVD
HPV Genotype 45 Primer Set
Fort Worth Diagnostics, LLC
HPV45002
In Commercial Distribution

  • 00850051429400 ()
HPV45002

  • Assay development analyte-specific reagent IVD
HPV Genotype 33 Primer Set
Fort Worth Diagnostics, LLC
HPV33002
In Commercial Distribution

  • 00850051429394 ()
HPV33002

  • Assay development analyte-specific reagent IVD
HPV Genotype 31 Primer Set
Fort Worth Diagnostics, LLC
HPV31002
In Commercial Distribution

  • 00850051429387 ()
HPV31002

  • Assay development analyte-specific reagent IVD
Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB002
In Commercial Distribution

  • 00850051429370 ()
BAB002

  • Assay development analyte-specific reagent IVD
Borrelia miyamotoi Primer Set
Fort Worth Diagnostics, LLC
MIY001
In Commercial Distribution

  • 00850051429363 ()
MIY001

  • Assay development analyte-specific reagent IVD
Babesia microti Primer Set
Fort Worth Diagnostics, LLC
BMI002
In Commercial Distribution

  • 00850051429349 ()
BMI002

  • Assay development analyte-specific reagent IVD
Adenovirus Primer Set
Fort Worth Diagnostics, LLC
ADV002
Not in Commercial Distribution

  • 00850051429332 ()
ADV002

  • Assay development analyte-specific reagent IVD
Ureaplasma Primer Set
Fort Worth Diagnostics, LLC
UREA002
In Commercial Distribution

  • 00850051429325 ()
UREA002

  • Assay development analyte-specific reagent IVD
Mycoplasma Primer Set
Fort Worth Diagnostics, LLC
MYCO002
In Commercial Distribution

  • 00850051429318 ()
MYCO002

  • Assay development analyte-specific reagent IVD
Megasphaera Primer Set
Fort Worth Diagnostics, LLC
MEGA002
In Commercial Distribution

  • 00850051429301 ()
MEGA002

  • Assay development analyte-specific reagent IVD
Gardnerella vaginalis Primer Set
Fort Worth Diagnostics, LLC
GAR002
In Commercial Distribution

  • 00850051429295 ()
GAR002

  • Assay development analyte-specific reagent IVD
Candida spp Primer Set
Fort Worth Diagnostics, LLC
CSPP002
In Commercial Distribution

  • 00850051429288 ()
CSPP002

  • Assay development analyte-specific reagent IVD
Candida krusei Primer Set
Fort Worth Diagnostics, LLC
KRU002
In Commercial Distribution

  • 00850051429271 ()
KRU002

  • Assay development analyte-specific reagent IVD
Candida glabrata Primer Set
Fort Worth Diagnostics, LLC
GLA002
In Commercial Distribution

  • 00850051429264 ()
GLA002

  • Assay development analyte-specific reagent IVD
BVAB2 Primer Set
Fort Worth Diagnostics, LLC
BVAB002
In Commercial Distribution

  • 00850051429257 ()
BVAB002

  • Assay development analyte-specific reagent IVD
Atopobium vaginae Primer Set
Fort Worth Diagnostics, LLC
ATO002
In Commercial Distribution

  • 00850051429240 ()
ATO002

  • Assay development analyte-specific reagent IVD
Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR002
In Commercial Distribution

  • 00850051429233 ()
BOR002

  • Assay development analyte-specific reagent IVD
JCV Primer Set
Fort Worth Diagnostics, LLC
JCV002
In Commercial Distribution

  • 00850051429226 ()
JCV002

  • Assay development analyte-specific reagent IVD
RSV Primer Set
Fort Worth Diagnostics, LLC
RSV001
In Commercial Distribution

  • 00850051429219 ()
RSV001

  • Assay development analyte-specific reagent IVD
Influenza B Primer Set
Fort Worth Diagnostics, LLC
FLUB001
In Commercial Distribution

  • 00850051429202 ()
FLUB001

  • Assay development analyte-specific reagent IVD
Influenza A Primer Set
Fort Worth Diagnostics, LLC
FLUA003
In Commercial Distribution

  • 00850051429196 ()
FLUA003

  • Assay development analyte-specific reagent IVD
Influenza A Primer Set
Fort Worth Diagnostics, LLC
FLUA001
In Commercial Distribution

  • 00850051429189 ()
FLUA001

  • Assay development analyte-specific reagent IVD
SARS-CoV-2 Primer Set
Fort Worth Diagnostics, LLC
COV001
In Commercial Distribution

  • 00850051429172 ()
COV001

  • Assay development analyte-specific reagent IVD
Ehrlichia Primer Set
Fort Worth Diagnostics, LLC
EHR002
In Commercial Distribution

  • 00850051429158 ()
EHR002

  • Assay development analyte-specific reagent IVD
Borrelia miyamotoi Primer Set
Fort Worth Diagnostics, LLC
MIY002
In Commercial Distribution

  • 00850051429141 ()
MIY002

  • Assay development analyte-specific reagent IVD
Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB002
Not in Commercial Distribution

  • 00850051429134 ()
BAB002

  • Assay development analyte-specific reagent IVD
Anaplasma Primer Set
Fort Worth Diagnostics, LLC
ANA002
Not in Commercial Distribution

  • 00850051429127 ()
ANA002

  • Assay development analyte-specific reagent IVD
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