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 Class Implantable

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Assayed control for RF, ASL and CRP assays on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10873684
In Commercial Distribution

  • 00630414287416 ()
  • 00630414284989 ()
OQDB17

  • Rheumatoid factor IVD, control
IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control
The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Siemens Healthcare Diagnostics Products GmbH
10465217
In Commercial Distribution

  • 00630414002736 ()
OVLI012

  • Nephelometry immunoassay analyser IVD
Growth Hormone CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128533
In Commercial Distribution

  • 00630414000213 ()
LGRHCVM

  • Human growth hormone (HGH) IVD, control
IMMULITE® 2000 Systems CCP Calibration Verification Material Anti-CCP IgG
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10718363
In Commercial Distribution

  • 00630414000206 ()
L2PICVM(D)

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Insulin Module - IMMULITE - CTL - 2x5mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10286614
In Commercial Distribution

  • 00630414998954 ()
LINCM

  • Insulin IVD, control
SHBG - IMMULITE - CTL - 1x1x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10285226
In Commercial Distribution

  • 00630414998947 ()
LSHCM

  • Sex hormone binding globulin (SHBG) IVD, control
Estriol unconjugated - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381192
In Commercial Distribution

  • 00630414997162 ()
L2KUE32

  • Free estriol (oestriol) IVD, kit, chemiluminescent immunoassay
No Description
Siemens Healthcare Diagnostics Products GmbH
10459379
Not in Commercial Distribution

  • 00630414992624 ()
B4132-10A

  • Differentiation solution IVD
For differential staining in hematology that gives results similar to a Wright-Giemsa stain
Siemens Healthcare Diagnostics Products GmbH
10459382
Not in Commercial Distribution

  • 00630414992617 ()
B4132-1A

  • Differentiation solution IVD
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