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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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Vysis LSI MYC SpectrumGreen Probe
ABBOTT MOLECULAR INC.
04N36-020
In Commercial Distribution

  • 00884999008359 ()
04N36-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYC SpectrumGold Probe
ABBOTT MOLECULAR INC.
04N35-020
In Commercial Distribution

  • 00884999008342 ()
04N35-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI LPL SpectrumOrange Probe
ABBOTT MOLECULAR INC.
04N34-020
In Commercial Distribution

  • 00884999008335 ()
04N34-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYB (6q23) SpectrumGold Probe
ABBOTT MOLECULAR INC.
04N33-020
In Commercial Distribution

  • 00884999008328 ()
04N33-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI RREB1 (6p25) SpectrumRed Probe
ABBOTT MOLECULAR INC.
04N32-020
In Commercial Distribution

  • 00884999008304 ()
04N32-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI D5S23, D5S721 SpectrumGreen Probes
ABBOTT MOLECULAR INC.
04N30-020
In Commercial Distribution

  • 00884999008274 ()
04N30-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI TOP2A 17q21-22 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
04N29-020
In Commercial Distribution

  • 00884999008267 ()
04N29-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI ZNF217 SpectrumGold Probe
ABBOTT MOLECULAR INC.
02N23-020
In Commercial Distribution

  • 00884999002746 ()
02N23-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYC (8q24) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
02N22-020
In Commercial Distribution

  • 00884999002739 ()
02N22-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI p16 (9p21) SpectrumRed Probe
ABBOTT MOLECULAR INC.
02N21-020
In Commercial Distribution

  • 00884999002722 ()
02N21-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI ERBB2 (17q12) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N20-020
In Commercial Distribution

  • 00884999002715 ()
02N20-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MAPT 17q21 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N19-010
In Commercial Distribution

  • 00884999002708 ()
02N19-010

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MYC (8q24) SpectrumRed Probe
ABBOTT MOLECULAR INC.
02N12-030
In Commercial Distribution

  • 00884999002623 ()
02N12-030

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI TERC (3q26) SpectrumGold Probe
ABBOTT MOLECULAR INC.
02N11-030
In Commercial Distribution

  • 00884999002609 ()
02N11-030

  • Nucleic acid hybridization detection IVD, probe
UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-095
In Commercial Distribution

  • 00884999002180 ()
02J27-095

  • Bladder tumour-associated mutation IVD, probe
UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-025
In Commercial Distribution

  • 00884999002142 ()
02J27-025

  • Bladder tumour-associated mutation IVD, probe
ProbeChek UroVysion Bladder Cancer Kit Control Slides
ABBOTT MOLECULAR INC.
02J27-011
In Commercial Distribution

  • 00884999002128 ()
02J27-011

  • Bladder tumour-associated mutation IVD, control
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 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 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
Vysis LSI CCND1 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
01N88-030
In Commercial Distribution

  • 00884999001305 ()
01N88-030

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI Xq13.2 (XIST) SO Probe
ABBOTT MOLECULAR INC.
01N61-001
In Commercial Distribution

  • 00884999000810 ()
01N61-001

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI BCL6 Dual Color Break Apart Rearrangement Probe
ABBOTT MOLECULAR INC.
01N23-020
In Commercial Distribution

  • 00884999000582 ()
01N23-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI MDM2 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
01N15-020
In Commercial Distribution

  • 00884999000513 ()
01N15-020

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI D15S10 SO/CEP 15 SA/PML SGn Probes
ABBOTT MOLECULAR INC.
01N13-010
In Commercial Distribution

  • 00884999000483 ()
01N13-010

  • Nucleic acid hybridization detection IVD, probe
Vysis LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/PML SpectrumGreen
ABBOTT MOLECULAR INC.
01N12-010
In Commercial Distribution

  • 00884999000476 ()
01N12-010

  • Nucleic acid hybridization detection IVD, probe
EXCAVATOR 20
AMERICAN EAGLE INSTRUMENTS, INC.
AEEXC20
In Commercial Distribution

  • 00841013104961 ()


  • Dental excavator, reusable
20 cm
Spiggle & Theis Medizintechnik GmbH
20-311-20
In Commercial Distribution

  • 04250381894361 ()
20-311-20

  • Bone file/rasp, manual, reusable
20 cm
Spiggle & Theis Medizintechnik GmbH
20-200-20
In Commercial Distribution

  • 04250381808405 ()
20-200-20

  • Dressing/utility forceps, scissors-like, reusable
20 cm
Spiggle & Theis Medizintechnik GmbH
10-720-21
In Commercial Distribution

  • 04250676732378 ()
10-720-21

  • Surgical mallet
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