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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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LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex - 10888234400035

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628917
In Commercial Distribution

  • 10888234400035 ()
628917

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B SSO Typing Kit for use with Luminex - 10888234400028

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628915
Not in Commercial Distribution

  • 10888234400028 ()
628915

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex - 10888234400011

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628913
In Commercial Distribution

  • 10888234400011 ()
628913

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-A SSO Typing Kit - 10888234400004

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628911
Not in Commercial Distribution

  • 10888234400004 ()
628911

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Alinity - 00380740165291

Alinity c Phencyclidine Reagent Kit 400 Tests
ABBOTT LABORATORIES
09P6620
In Commercial Distribution

  • 00380740165291 ()
09P6620

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

ABBOTT - 00380740011635

XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack
ABBOTT LABORATORIES
7A12-60
Not in Commercial Distribution

  • 00380740011635 ()
07A1260

  • Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

ABBOTT - 00380740011628

XSYSTEMS TDx/TDx Flx Methotrexate II Controls
ABBOTT LABORATORIES
7A12-10
Not in Commercial Distribution

  • 00380740011628 ()
07A1210

  • Methotrexate therapeutic drug monitoring IVD, control

ABBOTT - 00380740011611

XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators
ABBOTT LABORATORIES
7A12-01
Not in Commercial Distribution

  • 00380740011611 ()
07A1201

  • Methotrexate therapeutic drug monitoring IVD, calibrator

ARCHITECT - 00380740011529

Phencyclidine
ABBOTT LABORATORIES
6L96-20
In Commercial Distribution

  • 00380740011529 ()
06L9620

  • Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)

Phencyclidine Plus - 04015630998876

No Description
Roche Diagnostics GmbH
4490908190
In Commercial Distribution

  • 04015630998876 ()
4490908190

  • Phencyclidine (PCP) IVD, kit, chemiluminescent immunoassay
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