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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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Silaris RSV Control Kit - B54010290

The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test
MESA BIOTECH, INC.
1029
In Commercial Distribution

  • B54010290 ()
1029

  • Respiratory syncytial virus (RSV) nucleic acid IVD, control

Pointe Scientific, Inc. - 00811727013330

IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests.
POINTE SCIENTIFIC, INC.
P1035-96
In Commercial Distribution

  • 00811727013330 ()
P1035-96

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

Pointe Scientific, Inc. - 00811727012630

Carbon Dioxide Liquid Reagent, for the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use. 4 x 45mL
POINTE SCIENTIFIC, INC.
HC702-180
In Commercial Distribution

  • 00811727012630 ()
HC702-180

  • Carbon dioxide (CO2) IVD, calibrator

Albumin - 00817439020109

For the quantitative in vitro determination of Albumin in serum and plasma on the Polychem 180 analyzer. 9 x 51 ml
Medtest Dx, Inc.
ALB505
In Commercial Distribution

  • 00817439020109 ()
ALB505

  • Albumin IVD, kit, spectrophotometry

Teco Diagnostics Glucose (Hexokinase) Liquid Reagent - 10673486001662

Teco Diagnostics Glucose (Hexokinase) Liquid Reagent is used for the in vitro quantitative determination of glucose in human serum or plasma.
TECO DIAGNOSTICS
G516-150
In Commercial Distribution

  • 10673486001662 ()
G516-150

  • Glucose IVD, reagent

Medline-Microtek - 10748426140463

Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 in x 66 in)
Microtek Medical LLC
Surgical Slush - Hush-Slush Drape
In Commercial Distribution

  • 00748426140466 ()
  • 10748426140463 ()
ORS-330N

  • Medical equipment/instrument drape, single-use

Medline-Microtek - 10748426140449

Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 132 cm x 168 cm (52 in x 66 in)
Microtek Medical LLC
Surgical Slush - Hush-Slush Drape
In Commercial Distribution

  • 00748426140442 ()
  • 10748426140449 ()
ORS-321N

  • Medical equipment/instrument drape, single-use

Medline-Microtek - 10748426140432

Slush + Warmer Disc-Drape™, For use with ORS-1075HS Hush-Slush™ System, 112 cm x 168 cm (44 in x 66 in)
Microtek Medical LLC
Surgical Slush - Hush-Slush Drape
In Commercial Distribution

  • 00748426140435 ()
  • 10748426140432 ()
ORS-320N

  • Medical equipment/instrument drape, single-use

Medline-Microtek - 00748426140473

Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 132 cm x 168 cm (52 in x 66 in)
Microtek Medical LLC
Surgical Slush - Hush-Slush Drape
In Commercial Distribution

  • 10748426140470 ()
  • 00748426140473 ()
ORS-331

  • Medical equipment/instrument drape, single-use

Medline-Microtek - 00748426140459

Slush + Warmer Plate-Drape™, For use with ORS-1058 Hush-Slush™ System, 112 cm x 168 cm (44 in x 66 in)
Microtek Medical LLC
Surgical Slush - Hush-Slush Drape
In Commercial Distribution

  • 10748426140456 ()
  • 00748426140459 ()
ORS-330

  • Medical equipment/instrument drape, single-use
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