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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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Clinitek Status Connector - 00630414607962

The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system.
Siemens Healthcare Diagnostics Inc.
11537761
In Commercial Distribution

  • 00630414607962 ()
11537761

  • Urine analyser IVD, point-of-care

CLINITEK Novus® 10 Urinalysis Cassette 450 - 00630414602653

Cassette to be used on the CLINITEK Novus system for determination of 10 parameters. 450 tests guaranteed per cassette
Siemens Healthcare Diagnostics Inc.
10634643
In Commercial Distribution

  • 00630414602653 ()
10634643

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical

IMMULITE® 2000 Systems CCP Anti-CCP IgG - 00630414601991

CCP IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718148
In Commercial Distribution

  • 00630414601991 ()
L2KPI2(D)

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

ADVIA® 360/560 Dil (20L) - 00630414601274

ADVIA® 360/560 Dil 20L
Siemens Healthcare Diagnostics Inc.
11170845
In Commercial Distribution

  • 00630414601274 ()
D1512

  • Buffered sample diluent IVD

Atellica IM cPSA QC - 00630414598710

Complexed Prostate Specific Antigen (cPSA) QC Kit - Atellica IM - CLT 3 x 1 x 2.0mL
Siemens Healthcare Diagnostics Inc.
10995547
In Commercial Distribution

  • 00630414598710 ()
10995547

  • Complexed prostate specific antigen (cPSA) IVD, control

Atellica IM cPSA PRE - 00630414598703

Complexed Prostate Specific Antigen (cPSA) Pretreatment - Atellica IM - CONS (1PK) 1 x 5mL
Siemens Healthcare Diagnostics Inc.
10995546
In Commercial Distribution

  • 00630414598703 ()
10995546

  • Complexed prostate specific antigen (cPSA) IVD, reagent

Atellica IM cPSA - 00630414598680

Complexed Prostate Specific Antigen (cPSA) - Atellica IM - RGT - 100T
Siemens Healthcare Diagnostics Inc.
10995544
In Commercial Distribution

  • 00630414598680 ()
10995544

  • Complexed prostate specific antigen (cPSA) IVD, kit, chemiluminescent immunoassay

Atellica IM Calibrator Y - 00630414598475

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

Atellica CH UA - 00630414596334

Uric Acid (UA) Atellica CH - RGT 4800T
Siemens Healthcare Diagnostics Inc.
11097608
In Commercial Distribution

  • 00630414596334 ()
11097608

  • Uric acid IVD, kit, spectrophotometry

Atellica CH Amp - 00630414596068

Amphetamine (Amp) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097506
In Commercial Distribution

  • 00630414596068 ()
11097506

  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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