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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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Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 532
In Commercial Distribution

  • 00855005006041 ()
SA-06376

  • Ophthalmic solid-state laser system, photodisruption
Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution

  • 00686597010198 ()
90-1019

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Rapid Response FSH Menopause Test Cassette (Urine) - 25 tests/ kit for the qualitative detection of Follicle-stimulating hormone in urine.
BTNX Inc
FSH-1C25
In Commercial Distribution

  • 00722066005330 ()
  • 10722066005337 ()


  • Follicle stimulating hormone (FSH) IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma.
NANO-DITECH CORPORATION
TF8146
In Commercial Distribution

  • 00895160002519 ()
  • 10895160002516 ()
TF8146

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, fluorescent immunoassay
BHI AGAR with VANCOMYCIN (Brain Heart Infusion Agar with Vancomycin 6mcg/ml). For detecting vancomycin resistant Enterococcus spp. (VRE).
HARDY DIAGNOSTICS
G14
In Commercial Distribution

  • 00816576020102 ()
  • 00816576021215 ()
G14

  • VRE/HLARE agar culture medium IVD
ARK™ UR-144/JWH-018 Control is intended for use in quality control of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0003-00
In Commercial Distribution

  • 00812101030288 ()
5054-0003-00

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, control
ARK™ UR-144/JWH-018 Cutoff Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0002-02
In Commercial Distribution

  • 00812101030271 ()
5054-0002-02

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator
CK Reagent, for the quantitative determination of creatine kinase activity in serum. Size: 1 x 1L, 1 x 200ml
POINTE SCIENTIFIC, INC.
HC722-1200
In Commercial Distribution

  • 00811727014696 ()
HC722-1200

  • Total creatine kinase (CK) IVD, kit, enzyme spectrophotometry
ARK™ UR-144/JWH-018 Negative Calibrator is intended for use in calibration of the ARK™ UR-144/JWH-018 Assay.
ARK DIAGNOSTICS INC
5054-0002-01
In Commercial Distribution

  • 00812101030264 ()
5054-0002-01

  • Synthetic cannabinoid/synthetic cannabinoid metabolite IVD, calibrator
The device is a ultrasonic and thermal disinfection (intermediate level) device for the traetment of complex micro surgical instruments.
STEELCO SPA
US 300
In Commercial Distribution

  • 08054188818577 ()
US 300

  • Surgical utensil washer/disinfector
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