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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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AQC - 00860010518182

Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC305
In Commercial Distribution

  • 00860010518182 ()
AQC305

  • Sperm morphology/viability control IVD

AQC - 00860010518175

Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control

AQC - 00860010518168

Sperm Viability Quality Control. 2 stained and coverslipped sperm viability smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-viability-quality-control
Fertility Solutions, Inc.
AQC107
In Commercial Distribution

  • 00860010518168 ()
AQC107

  • Sperm morphology/viability control IVD

AQC - 00860010518151

Sperm Morphology Quality Control - Unstained. 2 unstained, fixed, glass sperm morphology smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC205
In Commercial Distribution

  • 00860010518151 ()
AQC205

  • Sperm morphology/viability control IVD

AQC - 00860010518144

Sperm Morphology Quality Control - Stained 2 Pap stained and coverslipped glass sperm morphology smears, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
Fertility Solutions, Inc.
AQC105
In Commercial Distribution

  • 00860010518144 ()
AQC105

  • Sperm morphology/viability control IVD

AQC - 08600105181752

Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
Not in Commercial Distribution

  • 08600105181752 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control

Unimed - 06945664802451

Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable

Autostat II Anti-Thyroid Peroxidase - 00816879020045

96 well ELISA for the detection of anti-TPO antibodies in human serum
HYCOR BIOMEDICAL LLC
FGA04
Not in Commercial Distribution

  • 00816879020045 ()


  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)

VOLATILES LEVEL 1 - B800UTAKWBCVOL1SD0

VOLATILES LEVEL 1
UTAK LABORATORIES, INC.
UTAK-WBC VOL 1 SD
In Commercial Distribution

  • B800UTAKWBCVOL1SD5 ()
  • B800UTAKWBCVOL1SD0 ()

  • Total Volume: 10 Milliliter
UTAK-WBC VOL 1 SD

  • Multiple-type clinical chemistry analyte profile IVD, control

VOLATILES PLUS LOW - B800VOLLMCV0

VOLATILES PLUS LOW
UTAK LABORATORIES, INC.
VOL+ L MCV
In Commercial Distribution

  • B800VOLLMCV0 ()

  • Total Volume: 5 Milliliter
VOL+ L MCV

  • Multiple-type clinical chemistry analyte profile IVD, control
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