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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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LABType™ CWD Class I B Locus Typing Test - 00814695022649

HLA A, B, C and DR locus typing to aid in transfusion and transplantation donor recipient matching
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022649 ()
RSSOW1B

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ CWD Class I A Locus Typing Test - 00814695022632

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

  • 00814695022632 ()
RSSOW1A

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

Micro SSP™ AmbiStrips™ HLA Class II -DRB40103N - 00814695021932

Micro SSP™ for the identification and assignment of HLA Class I and Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695021932 ()
SSPT1-G2

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ SAPE Buffer - 00814695020461

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

  • 00814695020461 ()
LTSPSAPBU

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ SAPE Buffer - 00814695020454

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

  • 00814695020454 ()
LTSPSAPBR

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

DrugCheck - B298310600

10 Panel Dip Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-THC
EXPRESS DIAGNOSTICS INT'L, INC.
31060
Not in Commercial Distribution

  • B298310600 ()
31060

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

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
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