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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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VITEK®2 - 03573026553968

VITEK ® 2 software 8.01 update, advanced software to run your VITEK ® 2 system
BIOMERIEUX , INC.
8.01
In Commercial Distribution

  • 03573026553968 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

VITEK®2 - 03573026145842

VITEK®2 XL is an automated system that performs large volumes of bacterial ID & AST testings
BIOMERIEUX , INC.
27222R
In Commercial Distribution

  • 03573026145842 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD

ViziShot 2 FLEX - 00821925043060

SINGLE USE ASPIRATION NEEDLE
Gyrus ACMI, LLC
NA-U403SX-4019
In Commercial Distribution

  • 00821925043060 ()


  • Body aspiration needle, single-use

CK NAC - 05055273201505

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.
RANDOX LABORATORIES LIMITED
CK3878
In Commercial Distribution

  • 05055273201505 ()
CK3878

  • Creatine kinase (CK) multiple isoenzyme IVD, reagent

AMY - 05055273200577

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1582
Not in Commercial Distribution

  • 05055273200577 ()
AY1582

  • Amylase isoenzyme IVD, reagent

AMY - 05055273200560

The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.
RANDOX LABORATORIES LIMITED
AY1580
In Commercial Distribution

  • 05055273200560 ()
AY1580

  • Amylase isoenzyme IVD, reagent

ALP - 05055273200362

An Alkaline Phosphatase test system is a device intended for the quantitative in vitro determination of Alkaline Phosphatase (ALP) activity in serum or plasma.
RANDOX LABORATORIES LIMITED
AP3877
In Commercial Distribution

  • 05055273200362 ()
AP3877

  • Alkaline phosphatase (ALP) isoenzyme IVD, reagent

STELA - 09336472002411

STELA PRIMER REFILL 5ML BT
SDI LIMITED
8640006
In Commercial Distribution

  • 09336472002411 ()
8640006

  • Dental composite resin

STELA - 09336472002367

STELA AUTOMIX 1 SYR REFILL
SDI LIMITED
8640001
In Commercial Distribution

  • 09336472002367 ()
8640001

  • Dental composite resin

Vivid Flavor Bite Chocolate Mint Super Fast Set - D724B3103881

2
PEARSON DENTAL SUPPLIES, INC.
B310388
In Commercial Distribution

  • D724B3103881 ()


  • Silicone dental impression material
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