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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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Tinto Cytokeratin 5 & 14, RMab - B502BSB66250

Tinto Cytokeratin 5 & 14 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB66250 ()
BSB 6625

  • Cytokeratin IVD, antibody

Cytokeratin 5 & 6 & ERG RMab - B502BSB66230

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB66230 ()
BSB 6623

  • Cytokeratin IVD, antibody

Cytokeratin 5 & 6 & ERG RMab - B502BSB66220

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB66220 ()
BSB 6622

  • Cytokeratin IVD, antibody

Cytokeratin 5 & 6 & ERG RMab - B502BSB66210

Cytokeratin 5 & 6 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB66210 ()
BSB 6621

  • Cytokeratin IVD, antibody

Cytokeratin 5 & ERG control slides - B502BSB66170

Cytokeratin 5 & ERG Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB66170 ()
BSB 6617

  • Cytokeratin IVD, control

Tinto Cytokeratin 5 & ERG, RMab - B502BSB66130

Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB66130 ()
BSB 6613

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & ERG, RMab - B502BSB66120

Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB66120 ()
BSB 6612

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & ERG, RMab - B502BSB66110

Cytokeratin 5 & ERG is a rabbit monoclonal antibody cocktail derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5.
BIO SB, INC.
predilute, 3 ml
In Commercial Distribution

  • B502BSB66110 ()
BSB 6611

  • Cytokeratin IVD, antibody

Cytokeratin 5 & 6 control slides - B502BSB66100

Cytokeratin 5 & 6 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB66100 ()
BSB 6610

  • Cytokeratin IVD, control

Tinto Cytokeratin 5 & 6, RMab - B502BSB66060

Tinto Cytokeratin 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB66060 ()
BSB 6606

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6, RMab - B502BSB66050

Tinto Cytokeratin 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB66050 ()
BSB 6605

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6, RMab - B502BSB66040

Tinto Cytokeratin 5 & 6 is a cocktail of rabbit monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB66040 ()
BSB 6604

  • Cytokeratin IVD, antibody

MedGyn Shaatz w/drain #5 - M803050125

Shaatz Pessary is used to treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Shaatz w/drain #5
In Commercial Distribution

  • M803050125 ()
050125

  • Pelvic-organ-supporting pessary

MedGyn Pessary Silicone Donut # 5 - M803050015

Pessary Silicone donut is used treat uterine prolapse.
MEDGYN PRODUCTS, INC.
Pessary Silicone Donut # 5
In Commercial Distribution

  • M803050015 ()
050015

  • Pelvic-organ-supporting pessary

Cytokeratin 5 & 6 control slides - B502BSB54060

Cytokeratin 5 & 6 Control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB54060 ()
BSB 5406

  • Cytokeratin IVD, control

Tinto Cytokeratin 5 & 6 (RM341) - B502BSB382270

Tinto Cytokeratin 5 & 6 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3822-7
In Commercial Distribution

  • B502BSB382270 ()

  • Total Volume: 7 Milliliter
BSB-3822-7

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6 (RM341) - B502BSB382230

Tinto Cytokeratin 5 & 6 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3822-3
In Commercial Distribution

  • B502BSB382230 ()

  • Total Volume: 3 Milliliter
BSB-3822-3

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6 (RM341) - B502BSB3822150

Tinto Cytokeratin 5 & 6 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
BSB-3822-15
In Commercial Distribution

  • B502BSB3822150 ()

  • Total Volume: 15 Milliliter
BSB-3822-15

  • Cytokeratin IVD, antibody

TintoFast CK 5/6 MMab - B502BSB36680

Anti-CK 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15ml
In Commercial Distribution

  • B502BSB36680 ()
BSB 3668

  • Cytokeratin IVD, antibody

TintoFast CK 5/6 MMab - B502BSB36670

Anti-CK 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7ml
In Commercial Distribution

  • B502BSB36670 ()
BSB 3667

  • Cytokeratin IVD, antibody

TintoFast CK 5/6 MMab - B502BSB36660

Anti-CK 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute 3ml
In Commercial Distribution

  • B502BSB36660 ()
BSB 3666

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6, MMab - B502BSB54020

Tinto Cytokeratin 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB54020 ()
BSB 5402

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6, MMab - B502BSB54010

Tinto Cytokeratin 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB54010 ()
BSB 5401

  • Cytokeratin IVD, antibody

Tinto Cytokeratin 5 & 6, MMab - B502BSB54000

Tinto Cytokeratin 5 & 6 is a cocktail of mouse monoclonal antibodies derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB54000 ()
BSB 5400

  • Cytokeratin IVD, antibody

DNA 5 Well Slide Pack - 00813545020682

No Description
SCIMEDX CORPORATION
6005
In Commercial Distribution

  • 00813545020682 ()
6005

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Elecsys Troponin T Gen 5 - 07613336158982

No Description
Roche Diagnostics GmbH
08469890160
In Commercial Distribution

  • 07613336158982 ()
08469890160

  • Troponin T IVD, reagent

Elecsys Troponin T Gen 5 - 07613336158951

Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Roche Diagnostics GmbH
08469865160
In Commercial Distribution

  • 07613336158951 ()
08469865160

  • Troponin T IVD, reagent

CalSet Troponin T Gen 5 - 07613336148280

No Description
Roche Diagnostics GmbH
08250499160
In Commercial Distribution

  • 07613336148280 ()
08250499160

  • Troponin T IVD, calibrator

Elecsys Troponin T Gen 5 - 07613336148273

No Description
Roche Diagnostics GmbH
08250472160
In Commercial Distribution

  • 07613336148273 ()
08250472160

  • Troponin T IVD, kit, enzyme immunoassay (EIA)

HANSATON stream remote 5.X - 07613389610932

A mobile app for HANSATON hearing instruments
Sonova AG
088-5018
In Commercial Distribution

  • 07613389610932 ()


  • Audiometric/hearing device software

LIQUIZIME PENTAENZIMATICO (5 Liter FB38) - 00810929045149

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
54319-61
In Commercial Distribution

  • 10810929045146 ()
  • 00810929045149 ()


  • Medical device cleaning agent

Class II Complement - 5 ml - 00812117014326

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014326 ()
CDR-5

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

Class I Complement - 5 ml - 00812117014302

Complement dependent cytotoxicity assays for determining HLA cell surface antigens.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014302 ()
CABC-5

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

Suture Washer, 3.5mm, 5 Hole - 00814289020723

No Description
CONVENTUS ORTHOPAEDICS, INC.
6038-1
In Commercial Distribution

  • 00814289020723 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Porous Wedge - Cotton 5 mm - 00813909013428

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5705
In Commercial Distribution

  • 00813909013428 ()

  • 16x5x22 mm
NB5705

  • Bone matrix implant, synthetic, non-antimicrobial

Hip 5 mm Grasper — Straight - 10810190013394

No Description
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
D
In Commercial Distribution

  • 10810190013394 ()
391400BSM

  • Clamp manipulation forceps

Reusable Safety Snap Leads (5) - 00817020020907

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M013953
In Commercial Distribution

  • 00817020020907 ()


  • Analytical scalp lead

AGG/PAK 5 Combo Kit - G0561076501

No Description
Bio/Data Corporation
107650
In Commercial Distribution

  • G0561076501 ()
107650

  • Platelet aggregation study IVD, kit, nephelometry/turbidimetry

ASSY,Reag.Disp.Card,PrepKit 5,BenchMark - 07613336125373

No Description
Ventana Medical Systems, Inc.
05251362001
In Commercial Distribution

  • 07613336125373 ()
05251362001

  • Assay container IVD, single-use

NexES Dispenser Card Fixative 5 - 07613336125137

No Description
Ventana Medical Systems, Inc.
05271665001
In Commercial Distribution

  • 07613336125137 ()
05271665001

  • Assay container IVD, single-use
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