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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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Tinto HER-2 neu, MMab - B502BSB56320

Tinto HER-2 neu is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB56320 ()
BSB 5632

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

Tinto HER-2 neu MMab - B502BSB56310

HER-2 neu is a mouse monoclonal antibody for immunohistochemistry derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB56310 ()
BSB 5631

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

HER-2 neu Control Slides - B502BSB9210CS0

HER-2 neu Control Slides
BIO SB, INC.
BSB-9210-CS
In Commercial Distribution

  • B502BSB9210CS0 ()
BSB-9210-CS

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

PathVysion - 00884999001855

ProbeChek PathVysion HER-2/neu Normal Control Slides
ABBOTT MOLECULAR INC.
02J05-030
In Commercial Distribution

  • 00884999001855 ()
02J05-030

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

Vysis - 00884999001848

ProbeChek PATHVISION HER-2/neu Normal Control Slides
ABBOTT MOLECULAR INC.
02J05-010
In Commercial Distribution

  • 00884999001848 ()
02J05-010

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

PathVysion - 00884999001831

ProbeChek PathVysion HER-2/neu Cut-Off Control Slides
ABBOTT MOLECULAR INC.
02J04-030
In Commercial Distribution

  • 00884999001831 ()
02J04-030

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

Vysis - 00884999001824

ProbeChek PathVysion HER-2/neu Cut-Off Control Slides
ABBOTT MOLECULAR INC.
02J04-010
In Commercial Distribution

  • 00884999001824 ()
02J04-010

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, control

PathVysion - 00884999001763

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-036
In Commercial Distribution

  • 00884999001763 ()
02J01-036

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent

PathVysion - 00884999001756

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-035
In Commercial Distribution

  • 00884999001756 ()
02J01-035

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent

PathVysion - 00884999001732

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-030
In Commercial Distribution

  • 00884999001732 ()
02J01-030

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent

ANTI-HER2/ERBB2 - 00810119670168

No Description
BIOGENEX LABORATORIES
AN726-10M
In Commercial Distribution

  • 00810119670168 ()

  • Total Volume: 10 Milliliter
AN726-10M

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

2" x 2" pigtail electrode - 20857771003594

1 Carton - 5 Inner Boxes / Carton, 10 Pouches / Inner Box, 10 Packs / Pouch. 4 Each / Pack
BIOMEDICAL LIFE SYSTEMS, INC.
EERC200M
In Commercial Distribution

  • 20857771003594 ()
EERC200M

  • Transcutaneous electrical stimulation electrode, single-use

TOTAL PROTEIN 2 (TP 2) - 05055273209518

No Description
RANDOX LABORATORIES LIMITED
TP8336
In Commercial Distribution

  • 05055273209518 ()


  • Total protein IVD, kit, spectrophotometry

TOTAL PROTEIN 2 (TP 2) - 05055273209501

No Description
RANDOX LABORATORIES LIMITED
TP8066
In Commercial Distribution

  • 05055273209501 ()


  • Total protein IVD, kit, spectrophotometry

TOTAL PROTEIN 2 (TP 2) - 05055273206562

For the quantitative in vitro determination of Total Protein in serum.
RANDOX LABORATORIES LIMITED
TP4001
In Commercial Distribution

  • 05055273206562 ()


  • Total protein IVD, kit, spectrophotometry

ACTICOAT 7 2" X 2" - 05000223455606

7 day silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20341
In Commercial Distribution

  • 00040565122038 ()
  • 05000223455606 ()
  • 30040565122039 ()
20341

  • Wound-nonadherent dressing, absorbent, antimicrobial

MACH 2 Double Stain 2 - 00847627009432

No Description
BIOCARE MEDICAL LLC
MRCT525H
In Commercial Distribution

  • 00847627009432 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Double Stain 2 - 00847627009425

No Description
BIOCARE MEDICAL LLC
MRCT525G
In Commercial Distribution

  • 00847627009425 ()


  • Immunohistochemistry antibody detection IVD, reagent

MACH 2 Double Stain 2 - 00847627009449

No Description
BIOCARE MEDICAL LLC
MRCT525L
In Commercial Distribution

  • 00847627009449 ()


  • Immunohistochemistry antibody detection IVD, reagent

API 2/2 Kit 1 - 05055272701341

No Description
KEELER LIMITED
1204-P-3100
In Commercial Distribution

  • 05055272701341 ()


  • Indirect binocular ophthalmoscope
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