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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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Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Home Access Health Corporation
80
In Commercial Distribution

  • M769CHOLESTEROL801 ()


  • Capillary blood collection set, home-use
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
No Description
W.H. Holden, Inc.
10-6121-D45
In Commercial Distribution

  • D928106121D450 ()


  • Dental suction system cannula, reusable
The Isoray Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.
ISORAY MEDICAL, INC.
PL-8
Not in Commercial Distribution

  • M748PL80 ()


  • General-purpose brachytherapy system applicator, manual
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-hydroxyprogesterone in saliva. Measurements of 17-hydroxyprogesterone are used as an aid in the diagnosis of various disorders of the adrenal glands or the ovaries, and as an aid in the diagnosis of late onset of 21-hydroxylase deficiency, a common cause of Congenital Adrenal Hyperplasia. This test is not intended for newborn screening.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
20-17OHU-E01-SLV
In Commercial Distribution

  • B2422017OHUE01SLV0 ()
20-17OHU-E01-SLV

  • 17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)
This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human Fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum, plasma (EDTA or Heparin), cell culture supernatant, tissue extracts and urine. The measurement of Fetuin-A in serum or plasma aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein. This Fetuin-A ELISA kit is for in vitro diagnostic use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
43-FETHU-E01
Not in Commercial Distribution

  • B24243FETHUE010 ()
43-FETHU-E01

  • Alpha-2-HS-glycoprotein (AHSG)/fetuin-A IVD, kit, enzyme immunoassay (EIA)
Waist One Stump Panty Closed
Gottfried Medical, Inc.
335
In Commercial Distribution

  • G420335 ()
335

  • Compression/pressure shirt/pants
Foot Web Spacer
Gottfried Medical, Inc.
022
In Commercial Distribution

  • G420022 ()
022

  • Compression/pressure glove
Integra® Jarit® Thorpe Caliper, 4-1/2", 0mm to 80mm in 1mm Increments
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
P4243
In Commercial Distribution

  • M274P42431 ()
  • 10381780214960 ()
P4243

  • General-purpose calliper, metallic
10mm 45° Laparoscope, Autoclavable, Made in Germany, Wide Angle View, with Blue Eye Piece
Surgical Direct, Inc.
SD810-450
In Commercial Distribution

  • B382SD8104500 ()
SD810-450

  • Rigid video laparoscope
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