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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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Autoimmune EIA Anti-Cardiolipin IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2020
In Commercial Distribution

  • 00847817018213 ()

  • 96 Tests
425-2020

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2000
In Commercial Distribution

  • 00847817018206 ()

  • 96 Tests
425-2000

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Kallestad Anti-Cyclic Citrullinated Peptides (CCP) II Microplate EIA
BIO-RAD LABORATORIES, INC.
96CP
In Commercial Distribution

  • 00847817000294 ()

  • 96 Tests
96CP

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
Calibrator Y - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995520
In Commercial Distribution

  • 00630414598475 ()
  • 00630414190914 ()
10995520

  • Complexed prostate specific antigen (cPSA) IVD, calibrator
Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry
Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Acetaminophen (Acet) Atellica CH - RGT 1200T
Siemens Healthcare Diagnostics Inc.
11097522
In Commercial Distribution

  • 00630414595894 ()
11097522

  • Acetaminophen IVD, kit, enzyme immunoassay (EIA)
Reagent tablets for the detection of Bilirubin in urine
Siemens Healthcare Diagnostics Inc.
10337316
In Commercial Distribution

  • 00630414595191 ()
A2591B24

  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
The CLINITEK Advantus urinalysis analyzer is a semi-automated, bench top analyzer. It is designed to read Siemens Healthcare Diagnostics Reagent Strips for Urinalysis, such as Multistix® 10 SG and Multistix PRO® Reagent Strips. This analyzer is intended for the measurement of the following: Bilirubin, Blood (occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine ratio, Specific Gravity, and Urobilinogen.
Siemens Healthcare Diagnostics Inc.
10636672
In Commercial Distribution

  • 00630414593562 ()
1420US

  • Urine analyser IVD, laboratory
CCP IgG Ab - CENTAUR - RGT - 100 tests
Siemens Healthcare Diagnostics Inc.
10699141
In Commercial Distribution

  • 00630414592312 ()
10699141

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
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