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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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DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011066 ()
RSSO1C

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011059 ()
RSSO1B

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011042 ()
RSSO1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Aspergillus Pooled Antiserum, 2mL
MICROBIOLOGICS INC.
200350
Not in Commercial Distribution

  • 10634853000435 ()
200350

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus Pooled Antigen, 1mL
MICROBIOLOGICS INC.
200345
Not in Commercial Distribution

  • 10634853000428 ()
200345

  • Multiple Aspergillus species antigen IVD, control
Aspergillus nidulans Antiserum, 2mL
MICROBIOLOGICS INC.
200290
Not in Commercial Distribution

  • 10634853000411 ()
200290

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus nidulans Antigen, 1mL
MICROBIOLOGICS INC.
200285
Not in Commercial Distribution

  • 10634853000404 ()
200285

  • Multiple Aspergillus species antigen IVD, control
Aspergillus terreus Antiserum, 2mL
MICROBIOLOGICS INC.
200280
Not in Commercial Distribution

  • 10634853000398 ()
200280

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus niger Antiserum, 2mL
MICROBIOLOGICS INC.
200215
Not in Commercial Distribution

  • 10634853000275 ()
200215

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus fumigatus Antiserum, 2mL
MICROBIOLOGICS INC.
200210
Not in Commercial Distribution

  • 10634853000268 ()
200210

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus flavus Antiserum, 2mL
MICROBIOLOGICS INC.
200205
Not in Commercial Distribution

  • 10634853000251 ()
200205

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus niger Antigen, 1mL
MICROBIOLOGICS INC.
200200
Not in Commercial Distribution

  • 10634853000244 ()
200200

  • Multiple Aspergillus species antigen IVD, control
Aspergillus fumigatus Antigen, 1mL
MICROBIOLOGICS INC.
200195
Not in Commercial Distribution

  • 10634853000237 ()
200195

  • Multiple Aspergillus species antigen IVD, control
Aspergillus flavus Antigen, 1mL
MICROBIOLOGICS INC.
200190
Not in Commercial Distribution

  • 10634853000220 ()
200190

  • Multiple Aspergillus species antigen IVD, control
Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
Candida Antigen, 1mL
MICROBIOLOGICS INC.
200180
Not in Commercial Distribution

  • 10634853000206 ()
200180

  • Candida albicans antigen IVD, control
Normal Rabbit Serum (Negative), 1mL
MICROBIOLOGICS INC.
200155
Not in Commercial Distribution

  • 10634853000169 ()
200155

  • Negative control immunoglobulin IVD
Histoplasma capsulatum Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200260
Not in Commercial Distribution

  • 10634853000121 ()
200260

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

  • 10634853000114 ()
200135

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

  • 10634853000107 ()
200245

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

  • 10634853000091 ()
200120

  • Histoplasma capsulatum antigen IVD, control
Coccidioides immitis Antiserum (HS), ID/EXO
MICROBIOLOGICS INC.
200270
Not in Commercial Distribution

  • 10634853000084 ()
200270

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

  • 10634853000077 ()
200145

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

  • 10634853000060 ()
200255

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

  • 10634853000053 ()
200130

  • Coccidioides immitis total antibody IVD, control
Blastomyces dermatitidis Antiserum, 2mL
MICROBIOLOGICS INC.
200140
Not in Commercial Distribution

  • 10634853000046 ()
200140

  • Blastomyces dermatitidis total antibody IVD, control
Blastomyces dermatitidis Antiserum, 1mL ID/EXO
MICROBIOLOGICS INC.
200265
Not in Commercial Distribution

  • 10634853000039 ()
200265

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

  • 10634853000022 ()
200250

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

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control
HCG Control Set Level B, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLB
In Commercial Distribution

  • 00817439020857 ()
HCG-CTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLB
In Commercial Distribution

  • 00817439020840 ()
HCGCTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
HCG Control Set Level A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 ml
Medtest Dx, Inc.
HCG-CTLA
In Commercial Distribution

  • 00817439020833 ()
HCG-CTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
Elevated HCG Control Vial Label - A, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLA
In Commercial Distribution

  • 00817439020826 ()
HCGCTLA

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
HCG Control Set, for In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 4 x 2.5 mL.
Medtest Dx, Inc.
HCG-CTL
In Commercial Distribution

  • 00817439020819 ()
HCG-CTL

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
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
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
for 18 detections of human HLA-B27 antigen in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823110
Not in Commercial Distribution

  • 07611969952908 ()
823110

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 6 detections of human HLA-DR/DQ antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823102
Not in Commercial Distribution

  • 07611969952885 ()
823102

  • HLA class II antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-AB antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823070
Not in Commercial Distribution

  • 07611969952854 ()
823070

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test
Bio-Rad Medical Diagnostics GmbH
823045
Not in Commercial Distribution

  • 07611969952830 ()
823045

  • HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)
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