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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 - 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

Fungal Serology - 10634853000435

Aspergillus Pooled Antiserum, 2mL
MICROBIOLOGICS INC.
200350
Not in Commercial Distribution

  • 10634853000435 ()
200350

  • Multiple Aspergillus species total antibody IVD, control

Fungal Serology - 10634853000428

Aspergillus Pooled Antigen, 1mL
MICROBIOLOGICS INC.
200345
Not in Commercial Distribution

  • 10634853000428 ()
200345

  • Multiple Aspergillus species antigen IVD, control

Fungal Serology - 10634853000411

Aspergillus nidulans Antiserum, 2mL
MICROBIOLOGICS INC.
200290
Not in Commercial Distribution

  • 10634853000411 ()
200290

  • Multiple Aspergillus species total antibody IVD, control

Fungal Serology - 10634853000404

Aspergillus nidulans Antigen, 1mL
MICROBIOLOGICS INC.
200285
Not in Commercial Distribution

  • 10634853000404 ()
200285

  • Multiple Aspergillus species antigen IVD, control

Fungal Serology - 10634853000398

Aspergillus terreus Antiserum, 2mL
MICROBIOLOGICS INC.
200280
Not in Commercial Distribution

  • 10634853000398 ()
200280

  • Multiple Aspergillus species total antibody IVD, control

Lymphostabil - 07611969953073

For conservation of lymphocytes, free of Ca and Mg, not for infusion
Bio-Rad Medical Diagnostics GmbH
824020
Not in Commercial Distribution

  • 07611969953073 ()
824020

  • Cell culture medium IVD
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