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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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Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL.
Medtest Dx, Inc.
HCGCTLB
In Commercial Distribution

  • 00817439020840 ()
HCGCTLB

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
SeCore® HLA Sequencing and GSSP kits are intended for the identification and definition of Class I and II Human Leukocyte Antigens (HLA).
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022830 ()
22110D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00814695022410 ()
54320D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Carpule.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-028 C
In Commercial Distribution

  • D801SP65028C1 ()
65-028

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-024
In Commercial Distribution

  • D801SP650241 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Part B. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-022
In Commercial Distribution

  • D801SP650221 ()
65-022

  • Dentine adhesive
Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B
TOPCON MEDICAL LASER SYSTEMS, INC.
Synthesis SLC & ESF 577
In Commercial Distribution

  • 00855005006058 ()
SA-06377

  • Ophthalmic solid-state laser system, photodisruption
No Description
ALYK, INC.
Personal Lubricant - .COM
In Commercial Distribution

  • 00851617007872 ()


  • General-body orifice lubricant, non-sterile
Self-Cured Resin for Sealing Occusal Fissures and Bonding Composite Restoratives to Etched Enamel.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 50-012
In Commercial Distribution

  • D801SP500121 ()
50-012

  • Dental pit/fissure sealant
AllSet+ Gold SSP is a PCR-based HLA typing evaluation method designed to provide low to high resolution of the HLA Class I (A, B, C) and Class II (DRB, DQB) Loci using genomic DNA.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017839 ()
54020D

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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