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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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Immunalysis - 00840937101568

PCP Urine HEIA™
IMMUNALYSIS CORP
308UR-0025
In Commercial Distribution

  • 00840937101568 ()
308UR-0025

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

VITROS - 10758750001842

VITROS Chemistry Products PCP Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6801998
In Commercial Distribution

  • 10758750001842 ()
  • 20758750001849 ()
6801998

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

Alinity - 00380740165291

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

  • 00380740165291 ()
09P6620

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

Emit® II Plus Phencyclidine Assay - 00842768023422

Emit® II Plus Phencyclidine Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445444
In Commercial Distribution

  • 00842768023422 ()
9J229

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

Dimension Vista® Flex® reagent cartridge PCP - 00842768015380

Urine Phencyclidine Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445115
In Commercial Distribution

  • 00842768015380 ()
  • 00630414004884 ()
K5094

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

Syva® Emit® II Plus Phencyclidine Assay - 00842768014406

Syva® Emit® II Plus Phencyclidine Assay - 29 mL Kit
Siemens Healthcare Diagnostics Inc.
10445442
In Commercial Distribution

  • 00842768014406 ()
9J039UL

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

Dimension® Flex® reagent cartridge PCP - 00842768005848

Urine Phencyclidine Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444924
In Commercial Distribution

  • 00842768005848 ()
  • 00630414004105 ()
DF94A

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

Syva® Emit® II Plus Phencyclidine Assay - 00842768001963

Syva® Emit® II Plus Phencyclidine Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445443
In Commercial Distribution

  • 00842768001963 ()
9J129UL

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

Syva® Emit® II Plus Phencyclidine Assay - 00842768001956

Syva® Emit® II Plus Phencyclidine Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445441
In Commercial Distribution

  • 00842768001956 ()
9J029UL

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

Immunalysis - 00840937110829

SEFRIA™ PCP Oral Fluid
IMMUNALYSIS CORP
608OF-0500
In Commercial Distribution

  • 00840937110829 ()
608OF-0500

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