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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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D3 Ultra - 30014613330301

D3 Ultra DFA Respiratory Virus Shell Vial Screening Set
DIAGNOSTIC HYBRIDS, INC.
01-010002.V2
In Commercial Distribution

  • 30014613330301 ()
01-010002.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330295

D3 Ultra DFA Respiratory Virus Direct Specimen Screening set
DIAGNOSTIC HYBRIDS, INC.
01-010001.V2
In Commercial Distribution

  • 30014613330295 ()
01-010001.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330288

D3 Ultra DFA Respiratory Virus Screening and ID kit
DIAGNOSTIC HYBRIDS, INC.
01-010000.V2
In Commercial Distribution

  • 30014613330288 ()
01-010000.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613330202

ELVIS SOL 3, 12ML
DIAGNOSTIC HYBRIDS, INC.
00-013012.V2
In Commercial Distribution

  • 30014613330202 ()
00-013012.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

ELVIS - 30014613330196

ELVIS SOL 3, 3ML
DIAGNOSTIC HYBRIDS, INC.
00-013003.V2
In Commercial Distribution

  • 30014613330196 ()
00-013003.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

D3 - 30014613338680

hMPV Antigen Control Slides
DIAGNOSTIC HYBRIDS, INC.
01-00070.v2
In Commercial Distribution

  • 30014613338680 ()
01-00070.v2

  • Human metapneumovirus (hMPV) antigen IVD, control

ELVIS - 30014613336020

INTL-ONLY ELVIS TYPE KIT 60-TE
DIAGNOSTIC HYBRIDS, INC.
I-SKT-ELVIS-60.V2
In Commercial Distribution

  • 30014613336020 ()
I-SKT-ELVIS-60.V2

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

DHI Specimen Collection System - 30014613335443

KIT, MALE WITH UTM
DIAGNOSTIC HYBRIDS, INC.
99-08012.V2
In Commercial Distribution

  • 30014613335443 ()
99-08012.V2

  • General specimen collection kit IVD, clinical

DHI Specimen Collection System - 30014613335436

KIT, FEMALE WITH UTM
DIAGNOSTIC HYBRIDS, INC.
99-08011.V2
In Commercial Distribution

  • 30014613335436 ()
99-08011.V2

  • General specimen collection kit IVD, clinical

LiDCO Ltd - 05060110522194

* INACTIVE Software Upgrade, LiDCO LXI v2 for ICU Medical only (b1326)
LIDCO LIMITED
Li11057
Not in Commercial Distribution

  • 05060110522194 ()
Li11057

  • General-purpose multi-parameter bedside monitor
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