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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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Fungal Serology - 10634853000275

Aspergillus niger Antiserum, 2mL
MICROBIOLOGICS INC.
200215
Not in Commercial Distribution

  • 10634853000275 ()
200215

  • Multiple Aspergillus species total antibody IVD, control

Fungal Serology - 10634853000268

Aspergillus fumigatus Antiserum, 2mL
MICROBIOLOGICS INC.
200210
Not in Commercial Distribution

  • 10634853000268 ()
200210

  • Multiple Aspergillus species total antibody IVD, control

Fungal Serology - 10634853000251

Aspergillus flavus Antiserum, 2mL
MICROBIOLOGICS INC.
200205
Not in Commercial Distribution

  • 10634853000251 ()
200205

  • Multiple Aspergillus species total antibody IVD, control

Fungal Serology - 10634853000244

Aspergillus niger Antigen, 1mL
MICROBIOLOGICS INC.
200200
Not in Commercial Distribution

  • 10634853000244 ()
200200

  • Multiple Aspergillus species antigen IVD, control

Fungal Serology - 10634853000237

Aspergillus fumigatus Antigen, 1mL
MICROBIOLOGICS INC.
200195
Not in Commercial Distribution

  • 10634853000237 ()
200195

  • Multiple Aspergillus species antigen IVD, control

Fungal Serology - 10634853000220

Aspergillus flavus Antigen, 1mL
MICROBIOLOGICS INC.
200190
Not in Commercial Distribution

  • 10634853000220 ()
200190

  • Multiple Aspergillus species antigen IVD, control

Fungal Serology - 10634853000213

Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control

Fungal Serology - 10634853000206

Candida Antigen, 1mL
MICROBIOLOGICS INC.
200180
Not in Commercial Distribution

  • 10634853000206 ()
200180

  • Candida albicans antigen IVD, control

Fungal Serology - 10634853000169

Normal Rabbit Serum (Negative), 1mL
MICROBIOLOGICS INC.
200155
Not in Commercial Distribution

  • 10634853000169 ()
200155

  • Negative control immunoglobulin IVD

Fungal Serology - 10634853000121

Histoplasma capsulatum Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200260
Not in Commercial Distribution

  • 10634853000121 ()
200260

  • Histoplasma capsulatum exoantigen IVD, control

Fungal Serology - 10634853000114

Histoplasma capsulatum Antiserum (H&M), 2mL
MICROBIOLOGICS INC.
200135
Not in Commercial Distribution

  • 10634853000114 ()
200135

  • Histoplasma capsulatum total antibody IVD, control

Fungal Serology - 10634853000107

Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO
MICROBIOLOGICS INC.
200245
Not in Commercial Distribution

  • 10634853000107 ()
200245

  • Histoplasma capsulatum exoantigen IVD, control

Fungal Serology - 10634853000091

Histoplasma capsulatum Antigen (H&M), 1mL
MICROBIOLOGICS INC.
200120
Not in Commercial Distribution

  • 10634853000091 ()
200120

  • Histoplasma capsulatum antigen IVD, control

Fungal Serology - 10634853000084

Coccidioides immitis Antiserum (HS), ID/EXO
MICROBIOLOGICS INC.
200270
Not in Commercial Distribution

  • 10634853000084 ()
200270

  • Coccidioides immitis exoantigen IVD, control

Fungal Serology - 10634853000077

Coccidioides immitis Antiserum (F), 2mL
MICROBIOLOGICS INC.
200145
Not in Commercial Distribution

  • 10634853000077 ()
200145

  • Coccidioides immitis total antibody IVD, control

Fungal Serology - 10634853000060

Coccidioides immitis Antigen (HS), 2mL ID/EXO
MICROBIOLOGICS INC.
200255
Not in Commercial Distribution

  • 10634853000060 ()
200255

  • Coccidioides immitis exoantigen IVD, control

Fungal Serology - 10634853000053

Coccidioides immitis Antigen (F), 1mL
MICROBIOLOGICS INC.
200130
Not in Commercial Distribution

  • 10634853000053 ()
200130

  • Coccidioides immitis total antibody IVD, control

Fungal Serology - 10634853000046

Blastomyces dermatitidis Antiserum, 2mL
MICROBIOLOGICS INC.
200140
Not in Commercial Distribution

  • 10634853000046 ()
200140

  • Blastomyces dermatitidis total antibody IVD, control

Fungal Serology - 10634853000039

Blastomyces dermatitidis Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200265
Not in Commercial Distribution

  • 10634853000039 ()
200265

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000022

Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control

Fungal Serology - 10634853000015

Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control

MassTrak™ - 00816776020001

Waters® MassTrak™ Immunosuppressants Kit
WATERS TECHNOLOGIES CORPORATION
186002891
In Commercial Distribution

  • 00816776020001 ()
186002891

  • Tacrolimus therapeutic drug monitoring IVD, control
  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Exact Diagnostics - 00812242030468

HSV-2 High Run Control
EXACT DIAGNOSTICS, LLC
HSV2H102
In Commercial Distribution

  • 00812242030468 ()
HSV2H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Exact Diagnostics - 00812242030451

HSV-2 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV2L101
In Commercial Distribution

  • 00812242030451 ()
HSV2L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Exact Diagnostics - 00812242030444

HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030437

HSV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HSV1H102
In Commercial Distribution

  • 00812242030437 ()
HSV1H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Exact Diagnostics - 00812242030420

HSV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV1L101
In Commercial Distribution

  • 00812242030420 ()
HSV1L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

Exact Diagnostics - 00812242030413

HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030406

HHV-6 High Run Control
EXACT DIAGNOSTICS, LLC
HV6H102
In Commercial Distribution

  • 00812242030406 ()
HV6H102

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control

Exact Diagnostics - 00812242030390

HHV-6 Low Run Control
EXACT DIAGNOSTICS, LLC
HV6L101
In Commercial Distribution

  • 00812242030390 ()
HV6L101

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control

Exact Diagnostics - 00812242030383

HHV-6B Verification Panel
EXACT DIAGNOSTICS, LLC
HV6BP100
In Commercial Distribution

  • 00812242030383 ()
HV6BP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030376

HHV-6A Verification Panel
EXACT DIAGNOSTICS, LLC
HV6AP100
In Commercial Distribution

  • 00812242030376 ()
HV6AP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030369

VZV High Run Control
EXACT DIAGNOSTICS, LLC
VZVH102
In Commercial Distribution

  • 00812242030369 ()
VZVH102

  • Varicella-zoster virus (VZV) nucleic acid IVD, control

Exact Diagnostics - 00812242030352

VZV Low Run Control
EXACT DIAGNOSTICS, LLC
VZVL101
In Commercial Distribution

  • 00812242030352 ()
VZVL101

  • Varicella-zoster virus (VZV) nucleic acid IVD, control

Exact Diagnostics - 00812242030345

VZV Verification Panel
EXACT DIAGNOSTICS, LLC
VZVP100
In Commercial Distribution

  • 00812242030345 ()
VZVP100

  • Varicella-zoster virus (VZV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030338

Adenovirus High Run Control
EXACT DIAGNOSTICS, LLC
ADVH102
In Commercial Distribution

  • 00812242030338 ()
ADVH102

  • Adenovirus nucleic acid IVD, control

Exact Diagnostics - 00812242030321

Adenovirus Low Run Control
EXACT DIAGNOSTICS, LLC
ADVL101
In Commercial Distribution

  • 00812242030321 ()
ADVL101

  • Adenovirus nucleic acid IVD, control

Exact Diagnostics - 00812242030314

Adenovirus Verification Panel
EXACT DIAGNOSTICS, LLC
ADVP100
In Commercial Distribution

  • 00812242030314 ()
ADVP100

  • Adenovirus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030222

HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030215

HCV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HCVAMR
In Commercial Distribution

  • 00812242030215 ()
HCVAMR

  • Hepatitis C virus nucleic acid IVD, calibrator
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