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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The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011431 ()
FL1HD10

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011424 ()
FL1HD09

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011417 ()
FL1HD08

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011400 ()
FL1HD07

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011394 ()
FL1HD06

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011387 ()
FL1HD05

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011370 ()
FL1HD04

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011363 ()
FL1HD03

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011356 ()
FL1HD02

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011349 ()
FL1HD01

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011332 ()
FL1HD

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011325 ()
FL2SP

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011301 ()
FL1SP

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011295 ()
FL2-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011288 ()
FL1-30

  • HLA class I & II antibody screening IVD, kit, multiplex
The FlowPRA Screening Test is intended for use in flow cytometric detection of panel reactive antibody (PRA) against pooled HLA Class I or Class II antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117011271 ()
FL12-60

  • HLA class I & II antibody screening IVD, kit, multiplex
u-Cup Drug Test Screen 12 Panel Drug Test Cup W/AD (AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/TCA/THC) (S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-3124
In Commercial Distribution

  • 20817038021815 ()
  • 10817038021818 ()
  • 00817038021811 ()
U-DUD-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 2 2/5" By 2 3/4" (60/70Mm)
CONVATEC, PURCHASING DEPARTMENT
416721
In Commercial Distribution

  • 10768455111913 ()
  • 00768455111916 ()
  • 00768455188352 ()


  • One-piece intestinal ostomy bag, open-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Transparent, 1 3/4 in. (45 mm)
CONVATEC, PURCHASING DEPARTMENT
413151
Not in Commercial Distribution

  • 10768455106124 ()
  • 00768455106127 ()
  • 80768455106123 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Transparent, 1 1/2 in. (38 mm)
CONVATEC, PURCHASING DEPARTMENT
413150
Not in Commercial Distribution

  • 10768455106117 ()
  • 00768455106110 ()
  • 80768455106116 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Transparent, 1 1/4 in. (32 mm)
CONVATEC, PURCHASING DEPARTMENT
413149
Not in Commercial Distribution

  • 10768455106100 ()
  • 00768455106103 ()
  • 80768455106109 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Opaque, 1 3/4 in. (45 mm)
CONVATEC, PURCHASING DEPARTMENT
413145
Not in Commercial Distribution

  • 10768455106063 ()
  • 00768455106066 ()
  • 80768455106062 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Opaque, 1 1/2 in. (38 mm)
CONVATEC, PURCHASING DEPARTMENT
413144
Not in Commercial Distribution

  • 10768455106056 ()
  • 00768455106059 ()
  • 80768455106055 ()


  • One-piece intestinal ostomy bag, closed-ended
ActiveLife One-Piece Pre-Cut Closed-End Pouch with Skin Barrier and No Tape Collar, with 1 Sided Comfort Panel and Filter, Opaque, 1 1/4 in. (32 mm)
CONVATEC, PURCHASING DEPARTMENT
413143
Not in Commercial Distribution

  • 10768455106049 ()
  • 00768455106042 ()
  • 80768455106048 ()


  • One-piece intestinal ostomy bag, closed-ended
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans, W/1 Sided Comfort Panel W/Tape Collar, 7/8" (22 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175778
In Commercial Distribution

  • 10768455102522 ()
  • 00768455102525 ()
  • 00768455181247 ()


  • One-piece intestinal ostomy bag, open-ended
CLIAwaived,Inc. IDTC- 12 Panel Cup with Adulterants (THC, COC, OPI 300, AMP, mAMP, PCP, BAR, BZO, MTD, OXY, MDMA, BUP + Cr, SG, OX)-(25T/KIT)
Cliawaived, Inc.
CLIA-IDTC-12BUPa
In Commercial Distribution

  • 00816610020808 ()
CLIA-IDTC-12BUPa

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Activelife® Convex One-Piece Pre-Cut Drainable Pouch With Durahesive® Skin Barrier, 12" Trans, W/1 Sided Comfort Panel W/Tape Collar, 3/4" (19 Mm.)
CONVATEC, PURCHASING DEPARTMENT
175777
In Commercial Distribution

  • 10768455102515 ()
  • 00768455102518 ()
  • 00768455181230 ()

  • Circumference: 19.00000 Millimeter


  • One-piece intestinal ostomy bag, open-ended
No Description
VAREX IMAGING CORPORATION
i5 RF
In Commercial Distribution

  • 00854344007061 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DR
In Commercial Distribution

  • 00854344007047 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
VAREX IMAGING CORPORATION
i5 DSA
In Commercial Distribution

  • 00854344007009 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 RF
Not in Commercial Distribution

  • 00858086006054 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DR
Not in Commercial Distribution

  • 00858086006016 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
INFIMED, INC.
i5 DSA
Not in Commercial Distribution

  • 00858086006009 ()


  • X-ray system computer, diagnostic, general-purpose
Control Swabs intended for use only with the ID NOW RSV product.
Alere Scarborough, Inc.
435-080
In Commercial Distribution

  • 10811877010538 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
In Commercial Distribution

  • 10811877010521 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Control Swabs intended for use only with the Alere i RSV product.
Alere Scarborough, Inc.
435-080
Not in Commercial Distribution

  • 10811877010132 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, control
A rapid, automated, molecular test for the qualitative detection of respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal specimens.
Alere Scarborough, Inc.
435-000
Not in Commercial Distribution

  • 10811877010118 ()


  • Respiratory syncytial virus (RSV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® AdV/hMPV/RV Controls Kit.
Hologic, Inc.
AMR CTRLS, PANTHER FUSION, IVD
In Commercial Distribution

  • 15420045509320 ()
PRD-04338

  • Multiple-genus respiratory virus nucleic acid IVD, control
The Panther Fusion® AdV/hMPV/RV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of Adenovirus (AdV), human Metapneumovirus (hMPV), and Rhinovirus (RV).
Hologic, Inc.
AMR KIT, PANTHER FUSION, 96T, IVD
In Commercial Distribution

  • 15420045509290 ()
PRD-04330

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
A qualitative one-step immunochromatographic test panel for the detection of THC (Cannabinoids), Opiates, Methamphetamine, Cocaine, Phencyclidine, Amphetamine, and Oxycodone drugs and/or their metabolites in human urine.
MEDTOX DIAGNOSTICS, INC.
605202
In Commercial Distribution

  • 00690286000506 ()
  • 10690286000503 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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