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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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Stratus® CS Acute Care™ ßhCG TestPak - 00842768004407

The Stratus® CS Acute Care™ Beta human Chorionic Gonadotropin method (ßhCG) is an in vitro diagnostic test for the quantitative measurement of the total beta subunit, vis, both the intact hCG dimer and the free ß subunit, of the human chorionic gonadotropin hormone in heparinized plasma.
Siemens Healthcare Diagnostics Inc.
10445060
In Commercial Distribution

  • 00842768004407 ()
  • 00630414009759 ()
CBHCG

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay

Syva® Emit® Ethyl Alcohol Low Control - 00842768001987

Syva® Emit® Ethyl Alcohol Low Control
Siemens Healthcare Diagnostics Inc.
10445447
In Commercial Distribution

  • 00842768001987 ()
9K049UL

  • Ethanol (ETOH) IVD, control

Syva® Emit® Ethyl Alcohol Negative Calibrator - 00842768001970

Syva® Emit® Ethyl Alcohol Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445445
In Commercial Distribution

  • 00842768001970 ()
9K029UL

  • Ethanol (ETOH) IVD, calibrator

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)

Syva® Emit® II Plus Cocaine Metabolite Assay - 00842768001932

Syva® Emit® II Plus Cocaine Metabolite Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445437
In Commercial Distribution

  • 00842768001932 ()
9H029UL

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Syva® Emit® II Plus Propoxyphene Assay - 00842768001925

Syva® Emit® II Plus Propoxyphene Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445435
In Commercial Distribution

  • 00842768001925 ()
9G129UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Propoxyphene Assay - 00842768001918

Syva® Emit® II Plus Propoxyphene Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445433
In Commercial Distribution

  • 00842768001918 ()
9G029UL

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Benzodiazepine Assay - 00842768001901

Syva® Emit® II Plus Benzodiazepine Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445431
In Commercial Distribution

  • 00842768001901 ()
9F129UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Barbiturate Assay - 00842768001888

Syva® Emit® II Plus Barbiturate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445424
In Commercial Distribution

  • 00842768001888 ()
9D129UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Barbiturate Assay - 00842768001871

Syva® Emit® II Plus Barbiturate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445422
In Commercial Distribution

  • 00842768001871 ()
9D029UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Amphetamines Assay - 00842768001864

Syva® Emit® II Plus Amphetamines Assay - 1L Kit
Siemens Healthcare Diagnostics Inc.
10445421
In Commercial Distribution

  • 00842768001864 ()
9C329UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Amphetamines Assay - 00842768001857

Syva® Emit® II Plus Amphetamines Assay - 115 mL
Siemens Healthcare Diagnostics Inc.
10445420
In Commercial Distribution

  • 00842768001857 ()
9C309UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Opiate Assay - 00842768001826

Syva® Emit® II Plus Opiate Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445417
In Commercial Distribution

  • 00842768001826 ()
9B329UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Opiate Assay - 00842768001819

Syva® Emit® II Plus Opiate Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445416
In Commercial Distribution

  • 00842768001819 ()
9B309UL

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Calibrator B Level 2 (high) - 00842768001802

Syva® Emit® Calibrator B Level 2 (high)
Siemens Healthcare Diagnostics Inc.
10445413
In Commercial Distribution

  • 00842768001802 ()
9A899UL

  • Amphetamine/methamphetamine group IVD, calibrator

Syva® Emit® Calibrator B Level 1 (cutoff) - 00842768001796

Syva® Emit® Calibrator B Level 1 (cutoff)
Siemens Healthcare Diagnostics Inc.
10445412
In Commercial Distribution

  • 00842768001796 ()
9A879UL

  • Amphetamine/methamphetamine group IVD, calibrator

Syva® Emit® Calibrator/Control Level 5 - 00842768001789

Syva® Emit® Calibrator/Control Level 5
Siemens Healthcare Diagnostics Inc.
10445411
In Commercial Distribution

  • 00842768001789 ()
9A609UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 4 - 00842768001772

Syva® Emit® Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10445410
In Commercial Distribution

  • 00842768001772 ()
9A589UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 3 - 00842768001765

Syva® Emit® Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10445409
In Commercial Distribution

  • 00842768001765 ()
9A569UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 2 - 00842768001758

Syva® Emit® Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10445408
In Commercial Distribution

  • 00842768001758 ()
9A549UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 1 - 00842768001741

Syva® Emit® Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10445407
In Commercial Distribution

  • 00842768001741 ()
9A529UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator/Control Level 0 (negative) - 00842768001734

Syva® Emit® Calibrator/Control Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445406
In Commercial Distribution

  • 00842768001734 ()
9A509UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® Calibrator Level 0 (negative) - 00842768001703

Syva® Emit® Calibrator Level 0 (negative)
Siemens Healthcare Diagnostics Inc.
10445403
In Commercial Distribution

  • 00842768001703 ()
9A049UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® 2000 Tacrolimus Calibrators - 00842768001680

Syva® Emit® 2000 Tacrolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445399
In Commercial Distribution

  • 00842768001680 ()
8R109UL

  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Tacrolimus Assay - 00842768001666

Syva® Emit® 2000 Tacrolimus Assay
Siemens Healthcare Diagnostics Inc.
10445397
In Commercial Distribution

  • 00842768001666 ()
8R019UL

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Salicylic Acid Calibrators - 00842768001628

Syva® Emit® tox Salicylic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445393
In Commercial Distribution

  • 00842768001628 ()
7S109UL

  • Salicylate IVD, calibrator

Syva® Emit® tox™ Salicylic Acid Assay - 00842768001611

Syva® Emit® tox Salicylic Acid Assay
Siemens Healthcare Diagnostics Inc.
10445392
In Commercial Distribution

  • 00842768001611 ()
7S019UL

  • Salicylate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Serum Barbiturate Assay - 00842768001604

Syva® Emit® tox Serum Barbiturate Assay
Siemens Healthcare Diagnostics Inc.
10445391
In Commercial Distribution

  • 00842768001604 ()
7D119UL

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Serum Benzodiazepine Assay - 00842768001581

Syva® Emit® tox Serum Benzodiazepine Assay
Siemens Healthcare Diagnostics Inc.
10445388
In Commercial Distribution

  • 00842768001581 ()
7B119UL

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® tox™ Serum Calibrators - 00842768001574

Syva® Emit® tox Serum Calibrators
Siemens Healthcare Diagnostics Inc.
10445387
In Commercial Distribution

  • 00842768001574 ()
7B019UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® tox™ Acetaminophen Calibrators - 00842768001567

Syva® Emit® tox Acetaminophen Calibrators
Siemens Healthcare Diagnostics Inc.
10445386
In Commercial Distribution

  • 00842768001567 ()
7A409UL

  • Acetaminophen IVD, calibrator

Syva® Emit® tox™ Acetaminophen Assay - 00842768001550

Syva® Emit® tox Acetaminophen Assay
Siemens Healthcare Diagnostics Inc.
10445385
In Commercial Distribution

  • 00842768001550 ()
7A319UL

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Amikacin Assay - 00842768001543

Syva® Emit® Amikacin Assay
Siemens Healthcare Diagnostics Inc.
10445383
In Commercial Distribution

  • 00842768001543 ()
6X019UL

  • Amikacin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Cyclosporine Pretreatment Reagent - 00842768001482

Syva® Emit® Cyclosporine Sample Pretreatment Reagent
Siemens Healthcare Diagnostics Inc.
10445378
In Commercial Distribution

  • 00842768001482 ()
  • 00630414010533 ()
6R719UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, reagent

Syva® Emit® 2000 Cyclosporine Specific Negative Calibrator - 00842768001475

Emit ® 2000 Cyclosporine Specific Negative Calibrator
Siemens Healthcare Diagnostics Inc.
10445377
In Commercial Distribution

  • 00842768001475 ()
  • 00630414024523 ()
6R319UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

Syva® Emit® 2000 Cyclosporine Specific Calibrators - 00842768001468

Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Cyclosporine Specific Assay - 00842768001451

Emit ® 2000 Cyclosporine Specific Assay
Siemens Healthcare Diagnostics Inc.
10445375
In Commercial Distribution

  • 00842768001451 ()
6R079UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Caffeine Control - 00842768001420

Syva® Emit® Caffeine Control
Siemens Healthcare Diagnostics Inc.
10445372
In Commercial Distribution

  • 00842768001420 ()
6P499UL

  • Caffeine IVD, control

Syva® Emit® Disopyramide Assay - 00842768001406

Syva® Emit® Disopyramide Assay
Siemens Healthcare Diagnostics Inc.
10445370
In Commercial Distribution

  • 00842768001406 ()
6N319UL

  • Disopyramide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Lidocaine Assay - 00842768001390

Syva® Emit® Lidocaine Assay
Siemens Healthcare Diagnostics Inc.
10445369
In Commercial Distribution

  • 00842768001390 ()
6M119UL

  • Lidocaine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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