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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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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 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 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

IMMULITE® Systems COR Calibration Verification Material Cortisol - 00630414977485

Cortisol Sample Diluent CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487396
In Commercial Distribution

  • 00630414977485 ()
LCOCVM

  • Total cortisol IVD, control

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

Fluoro Care Anti-Fade Mountant - 00847627002471

No Description
BIOCARE MEDICAL LLC
FP001G5
In Commercial Distribution

  • 00847627002471 ()


  • Microscopy mounting medium IVD

Fluoro Care Anti-Fade Mountant - 00847627002464

No Description
BIOCARE MEDICAL LLC
FP001G10
In Commercial Distribution

  • 00847627002464 ()


  • Microscopy mounting medium IVD

20q13.2 Aqua - 00847627000675

No Description
BIOCARE MEDICAL LLC
PFA7325V
In Commercial Distribution

  • 00847627000675 ()


  • Nucleic acid hybridization detection IVD, probe

TERC (3q26.2) Red - 00847627000651

No Description
BIOCARE MEDICAL LLC
PFA7305V
In Commercial Distribution

  • 00847627000651 ()


  • Nucleic acid hybridization detection IVD, probe

ERBB2 (17q12) Red - 00847627000637

No Description
BIOCARE MEDICAL LLC
PFA7274V
In Commercial Distribution

  • 00847627000637 ()


  • Nucleic acid hybridization detection IVD, probe

CDKN2A (9p21.3) Orange - 00847627000620

No Description
BIOCARE MEDICAL LLC
PFA7264V
In Commercial Distribution

  • 00847627000620 ()


  • Nucleic acid hybridization detection IVD, probe

ATM (11q22.3) Aqua - 00847627000613

No Description
BIOCARE MEDICAL LLC
PFA7263V
In Commercial Distribution

  • 00847627000613 ()


  • Nucleic acid hybridization detection IVD, probe

20q13.2 Orange - 00847627000606

No Description
BIOCARE MEDICAL LLC
PFA7255V
In Commercial Distribution

  • 00847627000606 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Red - 00847627000590

No Description
BIOCARE MEDICAL LLC
PFA7251V
In Commercial Distribution

  • 00847627000590 ()


  • Nucleic acid hybridization detection IVD, probe

5p15.2 Green - 00847627000583

No Description
BIOCARE MEDICAL LLC
PFA7250V
In Commercial Distribution

  • 00847627000583 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 17 Green - 00847627000576

No Description
BIOCARE MEDICAL LLC
PFA7225V
In Commercial Distribution

  • 00847627000576 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 15 Orange - 00847627000569

No Description
BIOCARE MEDICAL LLC
PFA7218V
In Commercial Distribution

  • 00847627000569 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 12 Aqua - 00847627000552

No Description
BIOCARE MEDICAL LLC
PFA7211V
In Commercial Distribution

  • 00847627000552 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 10 Green - 00847627000545

No Description
BIOCARE MEDICAL LLC
PFA7200V
In Commercial Distribution

  • 00847627000545 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Aqua - 00847627000538

No Description
BIOCARE MEDICAL LLC
PFA7185V
In Commercial Distribution

  • 00847627000538 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 7 Green - 00847627000521

No Description
BIOCARE MEDICAL LLC
PFA7184V
In Commercial Distribution

  • 00847627000521 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 6q11.1 Aqua - 00847627000514

No Description
BIOCARE MEDICAL LLC
PFA7179V
In Commercial Distribution

  • 00847627000514 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 6q11.1 Green - 00847627000507

No Description
BIOCARE MEDICAL LLC
PFA7178V
In Commercial Distribution

  • 00847627000507 ()


  • Nucleic acid hybridization detection IVD, probe

Copy Control 3 Aqua - 00847627000491

No Description
BIOCARE MEDICAL LLC
PFA7164V
In Commercial Distribution

  • 00847627000491 ()


  • Nucleic acid hybridization detection IVD, probe

RB1 (13q14.2) Green - 00847627000477

No Description
BIOCARE MEDICAL LLC
HFA7315A
In Commercial Distribution

  • 00847627000477 ()


  • Nucleic acid hybridization detection IVD, probe

1q21.3 Orange - 00847627000453

No Description
BIOCARE MEDICAL LLC
HFA7308A
In Commercial Distribution

  • 00847627000453 ()


  • Nucleic acid hybridization detection IVD, probe

TP53 (17p13) Orange - 00847627000439

No Description
BIOCARE MEDICAL LLC
HFA7306A
In Commercial Distribution

  • 00847627000439 ()


  • Nucleic acid hybridization detection IVD, probe

MYB (6q23) Orange - 00847627000415

No Description
BIOCARE MEDICAL LLC
HFA7283A
In Commercial Distribution

  • 00847627000415 ()


  • Nucleic acid hybridization detection IVD, probe

IGH (14q32) Constant Orange - 00847627000378

No Description
BIOCARE MEDICAL LLC
HFA7278A
In Commercial Distribution

  • 00847627000378 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Orange - 00847627000361

No Description
BIOCARE MEDICAL LLC
HFA7277A
In Commercial Distribution

  • 00847627000361 ()


  • Nucleic acid hybridization detection IVD, probe

FGFR3 (4p16.3) Aqua - 00847627000354

No Description
BIOCARE MEDICAL LLC
HFA7276A
In Commercial Distribution

  • 00847627000354 ()


  • Nucleic acid hybridization detection IVD, probe

D13S319 (13q14.2) Orange - 00847627000347

No Description
BIOCARE MEDICAL LLC
HFA7267A
In Commercial Distribution

  • 00847627000347 ()


  • Nucleic acid hybridization detection IVD, probe

D13S25 (13q14.3) Orange - 00847627000330

No Description
BIOCARE MEDICAL LLC
HFA7266A
In Commercial Distribution

  • 00847627000330 ()


  • Nucleic acid hybridization detection IVD, probe
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