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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 - 00847817018213

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 - 00847817018206

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 - 00847817000294

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)

ARCHV – Antigen Retrieval Chamber High Voltage (Recertified) - 00847627035509

No Description
BIOCARE MEDICAL LLC
DCARC0003-R
In Commercial Distribution

  • 00847627035509 ()


  • Pressurized incubator IVD

AMACR (RM) - 00847627029706

No Description
BIOCARE MEDICAL LLC
AVA3024G
In Commercial Distribution

  • 00847627029706 ()


  • p504s protein IVD, antibody

AMACR (RM) - 00847627029690

No Description
BIOCARE MEDICAL LLC
ALA3024G7
In Commercial Distribution

  • 00847627029690 ()


  • p504s protein IVD, antibody

AMACR (RM) - 00847627025197

No Description
BIOCARE MEDICAL LLC
OPAA3024T60
In Commercial Distribution

  • 00847627025197 ()


  • p504s protein IVD, antibody

GLIDEWIRE - 04987350734822

GLIDEWIRE GT Guide Wire
TERUMO CORPORATION
RG*GE1818SP
In Commercial Distribution

  • 54987350734827 ()
  • 04987350734822 ()

  • STANDARD
  • Length: 180 Centimeter
  • Angled(90 Degree)
  • Outer Diameter: 0.46 Millimeter
RG*GE1818SP

  • Cardiac/peripheral vascular guidewire, single-use

GLIDEWIRE - 04987350734808

GLIDEWIRE GT Guide Wire
TERUMO CORPORATION
RG*GA1818SP
In Commercial Distribution

  • 54987350734803 ()
  • 04987350734808 ()

  • STANDARD
  • Length: 180 Centimeter
  • Angled(45 Degree)
  • Outer Diameter: 0.46 Millimeter
RG*GA1818SP

  • Cardiac/peripheral vascular guidewire, single-use

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981147

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10697937
In Commercial Distribution

  • 00630414981147 ()
10697937

  • Urine analyser IVD, laboratory

CLINITEK Novus® Automated Urine Chemistry Analyzer - 00630414981130

The CLINITEK Novus® Automated Urine Chemistry analyzer is a fully automated urinalysis instrument for clinical laboratory use. The CLINITEK Novus Analyzer is intended to read Siemens Healthcare Diagnostics CLINITEK Novus cassettes, as well as determine urine specific gravity and urine clarity. The CLINITEK Novus cassettes are intended for the semi-quantitative measurement of the following parameters in urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leu
Siemens Healthcare Diagnostics Inc.
10494134
In Commercial Distribution

  • 00630414981130 ()
10494134

  • Urine analyser IVD, laboratory

DSG-1 & DSG-3 ELISA Test System - 04987506017434

The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases.
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
DSG1 48 wells and DSG3 48 wells.
In Commercial Distribution

  • 04987506017434 ()
7594US

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

DSG-1 & DSG-3 ELISA Test System - 04987506015942

The DSG-1 & DSG-3 ELISA Test System is a semi-quantitative enzyme-linked immunosorbent assay for the determination of autoantibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in human serum. The DSG-1 & DSG-3 ELISA Test System is intended for in vitro diagnostic use as an aid in diagnosis of certain pemphigus diseases. https://www.mblintl.com/products/rg-m7593-d
MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
DSG1 48 wells and DSG3 48 wells.
Not in Commercial Distribution

  • 04987506015942 ()
7593US

  • Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) antibody IVD, kit, enzyme immunoassay (EIA)

Atellica CH Protein 1 Calibrator (PROT 1 CAL) - 00630414636672

Protein 1 Calibrator
Siemens Healthcare Diagnostics Inc.
11537520
In Commercial Distribution

  • 00630414313467 ()
  • 00630414636672 ()
11537520

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2) - 00630414628707

Gamma-Glutamyl Transferase (GGT_2) Reagents
Siemens Healthcare Diagnostics Inc.
11537248
In Commercial Distribution

  • 00630414313382 ()
  • 00630414628707 ()
11537248

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

ATELLICA IM NT-PBNPII (PBNPII) - 00630414626970

PBNPII - ATELLICA IM - MCM Set
Siemens Healthcare Diagnostics Inc.
11204754
In Commercial Distribution

  • 00630414626970 ()
11204754

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

ADVIA Centaur NT-PBNPII (PBNPII) - 00630414626963

PBNPII - ADVIA Centaur - MCM Set
Siemens Healthcare Diagnostics Inc.
11204753
In Commercial Distribution

  • 00630414626963 ()
11204753

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, control

Atellica CH Billirubin Calibrator (BILI CAL) - 00630414615097

Atellica CH Bilirubin Calibrator (BILI CAL)
Siemens Healthcare Diagnostics Inc.
11537243
In Commercial Distribution

  • 00630414313450 ()
  • 00630414615097 ()
11537243

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Atellica CH Prealbumin (PALB) - 00630414614939

Atellica CH Prealbumin (PALB)
Siemens Healthcare Diagnostics Inc.
11537217
In Commercial Distribution

  • 00630414313412 ()
  • 00630414614939 ()
11537217

  • Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetry

Atellica CH Diazo Total Bilirubin (D_TBil) - 00630414614922

Atellica CH Diazo Total Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537220
In Commercial Distribution

  • 00630414313436 ()
  • 00630414614922 ()
11537220

  • Total bilirubin IVD, kit, spectrophotometry

Atellica CH Diazo Direct Bilirubin (D_DBil) - 00630414614755

Atellica CH Diazo Direct Bilirubin (D_TBil)
Siemens Healthcare Diagnostics Inc.
11537219
In Commercial Distribution

  • 00630414313429 ()
  • 00630414614755 ()
11537219

  • Conjugated (direct) bilirubin IVD, kit, spectrophotometry

Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) - 00630414611112

Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
Siemens Healthcare Diagnostics Inc.
11537224
In Commercial Distribution

  • 00630414305028 ()
  • 00630414611112 ()
11537224

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Atellica CH Revised C-Reactive Protein (RCRP) - 00630414610887

Atellica CH C-Reactive Protein (RCRP) Reagent
Siemens Healthcare Diagnostics Inc.
11537223
In Commercial Distribution

  • 00630414305127 ()
  • 00630414610887 ()
11537223

  • C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

Atellica CH Anti-Streptolysin-O_3 (ASO_3) - 00630414610856

Antistreptolysin O (ASO_3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537212
In Commercial Distribution

  • 00630414305097 ()
  • 00630414610856 ()
11537212

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry

Atellica CH Iron3 (Iron3) - 00630414610849

Iron (Iron3) Atellica CH
Siemens Healthcare Diagnostics Inc.
11537211
In Commercial Distribution

  • 00630414305011 ()
  • 00630414610849 ()
11537211

  • Iron IVD, kit, spectrophotometry

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
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