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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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ADVIA Centaur® iPTH Calibrator - 00630414587486

PTH intact - CENTAUR - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

CD68 [KP1] BSA Free (1.0mg/ml) - 00847627031556

No Description
BIOCARE MEDICAL LLC
ACC033CFW
In Commercial Distribution

  • 00847627031556 ()


  • CD68 cell marker IVD, antibody

CD3 [BC33] BSA Free (1.0mg/ml) - 00847627024718

Alternate name : CD3 [BC33]
BIOCARE MEDICAL LLC
ACC3170CFW
In Commercial Distribution

  • 00847627024718 ()


  • CD3 cell marker IVD, antibody

CD8 [C8/144B] BSA Free (1.0mg/ml) - 00847627024701

Alternate name : CD8 [C8/144B]
BIOCARE MEDICAL LLC
ACC3160CFW
In Commercial Distribution

  • 00847627024701 ()


  • CD8 cell marker IVD, antibody

CD45RO [UCHL-1] BSA Free (1.0mg/ml) - 00847627024695

Alternate name : CD45RO [UCHL-1]
BIOCARE MEDICAL LLC
ACC006CFW
In Commercial Distribution

  • 00847627024695 ()


  • CD45RO cell marker IVD, antibody

SOX10 [BC34] BSA Free (1.0mg/ml) - 00847627024688

No Description
BIOCARE MEDICAL LLC
ACC3099CFW
In Commercial Distribution

  • 00847627024688 ()


  • SOXE protein IVD, antibody

p40 [BC28] BSA Free (1.0mg/ml) - 00847627024619

No Description
BIOCARE MEDICAL LLC
ACC3066CF
In Commercial Distribution

  • 00847627024619 ()


  • p40 protein IVD, antibody

p40 [BC28] BSA Free (1.0mg/ml) - 00847627024404

No Description
BIOCARE MEDICAL LLC
ACC3066CFW
In Commercial Distribution

  • 00847627024404 ()


  • p40 protein IVD, antibody

CD3 [BC33] BSA Free (1.0mg/ml) - 00847627014825

Alternate name : CD3 [BC33]
BIOCARE MEDICAL LLC
ACC3170CF
In Commercial Distribution

  • 00847627014825 ()


  • CD3 cell marker IVD, antibody

CD8 [C8/144B] BSA Free (1.0mg/ml) - 00847627014818

Alternate name : CD8 [C8/144B]
BIOCARE MEDICAL LLC
ACC3160CF
In Commercial Distribution

  • 00847627014818 ()


  • CD8 cell marker IVD, antibody

SOX10 [BC34] BSA Free (1.0mg/ml) - 00847627014801

No Description
BIOCARE MEDICAL LLC
ACC3099CF
In Commercial Distribution

  • 00847627014801 ()


  • SOXE protein IVD, antibody

CD68 [KP1] BSA Free (1.0mg/ml) - 00847627014795

Alternate name : CD68 [KP1]
BIOCARE MEDICAL LLC
ACC033CF
In Commercial Distribution

  • 00847627014795 ()


  • CD68 cell marker IVD, antibody

CD45RO [UCHL-1] BSA Free (1.0mg/ml) - 00847627014788

Alternate name : CD45RO [UCHL-1]
BIOCARE MEDICAL LLC
ACC006CF
In Commercial Distribution

  • 00847627014788 ()


  • CD45RO cell marker IVD, antibody

IMMULITE® Systems T4 Calibration Verification Material Total T4 - 00630414973807

TOTAL T4 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388142
In Commercial Distribution

  • 00630414973807 ()
LT4CVM

  • Total thyroxine (TT4) IVD, control

IMMULITE® Systems INS Calibration Verification Material Insulin - 00630414973708

Insulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388005
In Commercial Distribution

  • 00630414973708 ()
LINCVM

  • Insulin IVD, control

IMMULITE® Systems HPG Calibration Verification Material H. pylori IgG - 00630414973678

H. Pylori CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387993
In Commercial Distribution

  • 00630414973678 ()
LHPGCVM

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems HCY Calibration Verification Material Homocysteine - 00630414973661

Homocysteine CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387991
In Commercial Distribution

  • 00630414973661 ()
LHOCVM

  • Homocysteine IVD, control

IMMULITE® Systems IG1 Calibration Verification Material IGF-1 - 00630414973647

IGF-I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387979
In Commercial Distribution

  • 00630414973647 ()
LGFCVM

  • Insulin-like growth factor I (IGF1) IVD, control

IMMULITE® Systems FT3 Calibration Verification Material Free T3 - 00630414973593

FreeT3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387963
In Commercial Distribution

  • 00630414973593 ()
LF3CVM

  • Free triiodothyronine (FT3) IVD, control

IMMULITE® Systems VB Calibration Verification Material Vitamin B12 - 00630414971421

Vitamin B12 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373710
In Commercial Distribution

  • 00630414971421 ()
LVBCVM

  • Vitamin B12 IVD, control

IMMULITE® Systems T3 Calibration Verification Material Total T3 - 00630414971360

Total T3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373704
In Commercial Distribution

  • 00630414971360 ()
LT3CVM

  • Total triiodothyronine (TT3) IVD, control

IMMULITE Systems Rubella Quantitative IgG CVM - 00630414973784

Rubella Quantitative IgG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388114
In Commercial Distribution

  • 00630414973784 ()
LRUBCVM

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems TIE Calibration Verification Material Total IgE - 00630414973692

IgE Total CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388001
In Commercial Distribution

  • 00630414973692 ()
LIECVM

  • Total immunoglobulin E (IgE total) IVD, control

IMMULITE® Systems GAS Calibration Verification Material Gastrin - 00630414973630

Gastrin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387978
In Commercial Distribution

  • 00630414973630 ()
LGACVM

  • Gastrin IVD, control

IMMULITE® Systems FSH Calibration Verification Material FSH - 00630414973623

FSH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387977
In Commercial Distribution

  • 00630414973623 ()
LFSCVM

  • Follicle stimulating hormone (FSH) IVD, control

IMMULITE® Systems HCG Calibration Verification Material HCG - 00630414973562

HCG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387900
In Commercial Distribution

  • 00630414973562 ()
LCGCVM

  • Total human chorionic gonadotropin IVD, control

IMMULITE Systems Beta-2 Microglobulin CVM - 00630414973555

Beta-2 Microglobulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387885
In Commercial Distribution

  • 00630414973555 ()
LBMCVM

  • Beta-2-microglobulin IVD, control

IMMULITE® TOXOPLASMA QUANT. CVM - 00630414971414

Toxoplasma Quantitative CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373709
In Commercial Distribution

  • 00630414971414 ()
LTXPCVM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems TBG Calibration Verification Material TBG - 00630414971377

TBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373705
In Commercial Distribution

  • 00630414971377 ()
LTBCVM

  • Thyroxine binding globulin (TBG) IVD, control

IMMULITE® Systems fPS Calibration Verification Material Free PSA - 00630414971346

Free PSA CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373702
In Commercial Distribution

  • 00630414971346 ()
LPFCVM

  • Free (unbound) prostate specific antigen (fPSA) IVD, control

IMMULITE® Systems DPD Calibration Verification Material Pyrilinks-D - 00630414971322

Pyrilinks-D CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373700
In Commercial Distribution

  • 00630414971322 ()
LPDCVM

  • Cyclic adenosine monophosphate (cAMP) IVD, control

IMMULITE® Systems MYO Calibration Verification Material Myoglobin - 00630414971292

Myoglobin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373696
In Commercial Distribution

  • 00630414971292 ()
LMYCVM

  • Myoglobin IVD, control

IMMULITE® Systems BP-3 Calibration Verification Material IGBP-3 - 00630414971254

IGFBP-3 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373692
In Commercial Distribution

  • 00630414971254 ()
LGBCVM

  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control

IMMULITE® Systems F4 Calibration Verification Material Free T4 - 00630414971247

Free T4 CVM - IMMULITE -
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373691
In Commercial Distribution

  • 00630414971247 ()
LFT4CVM

  • Free thyroxine (FT4) IVD, control

IMMULITE 2000 Systems Folic Acid Calibration Verification Material - 00630414971230

Folate Acid CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373690
In Commercial Distribution

  • 00630414971230 ()
LFOCVM

  • Folate (vitamin B9) IVD, control

IMMULITE® Systems E2 Calibration Verification Material Estradiol - 00630414971216

Estradiol CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373688
In Commercial Distribution

  • 00630414971216 ()
LE2CVM

  • Estradiol (oestradiol) (E2) IVD, control

Dimension Vista® CHEM 1 CAL - 00630414948508

Chemistry 1 Calibrator, 6 (3A x 2.3 mL; 3B x 2.3 mL)
Siemens Healthcare Diagnostics Inc.
10716281
Not in Commercial Distribution

  • 00630414948508 ()
KC110B

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

IMMULITE® 3RD GEN. PSA CVM - 00630414601939

3rd Generation PSA CVM - IMMULITE – CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10713725
In Commercial Distribution

  • 00630414601939 ()
L3PSCVM

  • Total prostate specific antigen (tPSA) IVD, control

Low-Tox-H Rabbit Complement - 00628451099208

Low-Tox®-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3335
In Commercial Distribution


  • Total Volume: 10 Milliliter
CL3335

  • Complement reagent IVD

Low-Tox-H Rabbit Complement - 00628451099192

Low-Tox-H Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3331
In Commercial Distribution


  • Total Volume: 10 Milliliter
CL3331

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099161

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3120
In Commercial Distribution


  • Total Volume: 100 Milliliter
CL3120

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099154

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3115
In Commercial Distribution


  • Total Volume: 25 Milliliter
CL3115

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099147

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3113
In Commercial Distribution


  • Total Volume: 3 Milliliter
CL3113

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099130

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3112
In Commercial Distribution


  • Total Volume: 20 Milliliter
CL3112

  • Complement reagent IVD

Standard Rabbit Complement - 00628451099123

Standard Rabbit Complement, Lyophilized
Cedarlane Corporation
CL3111
In Commercial Distribution


  • Total Volume: 25 Milliliter
CL3111

  • Complement reagent IVD

IMMULITE® 2000 TSI CVM - 00630414006680

IMMULITE(R) 2000 TSI CVM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10715502
In Commercial Distribution

  • 00630414006680 ()
L2SICVM

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, control

Alinity - 00380740155377

Alinity I Intact PTH Controls
Abbott GmbH
08P3111
In Commercial Distribution

  • 00380740155377 ()
08P3111

  • Parathyroid hormone (PTH) IVD, control

ARCHITECT - 00380740175474

ARCHITECT STAT High Sensitivity Troponin-I Calibrators
ABBOTT IRELAND
02R9801
In Commercial Distribution

  • 00380740175474 ()
02R9801

  • Troponin I IVD, calibrator

ARCHITECT - 00380740156039

ARCHITECT Intact PTH Calibrators
Abbott GmbH
08K2504
In Commercial Distribution

  • 00380740156039 ()
08K2504

  • Parathyroid hormone (PTH) IVD, calibrator
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