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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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Entry, TCA - 06438153000129

Entry, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices.
Thermo Fisher Scientific Oy
1
In Commercial Distribution

  • 06438153000129 ()
952015

  • Specimen processing instrument IVD

Interface, TCA ARCHITECT i2000SR - 06438153000099

Interface, TCA ARCHITECT i2000SR is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices.
Thermo Fisher Scientific Oy
1
In Commercial Distribution

  • 06438153000099 ()
952234

  • Specimen processing instrument IVD

VIDAS® 3 SAMPLE TIPS - 03573026615277

This single-use tips are used by the VIDAS®3 pipetting unit to pipette the samples according to the defined loading plan.
BIOMERIEUX SA
VIDAS® 3 SAMPLE TIPS
In Commercial Distribution

  • 03573026377434 ()
  • 03573026615277 ()
  • 03573026615260 ()


  • Pipette tip IVD

Nova - 10385480634127

Sample Cups: 0.5 ml x 1000
NOVA BIOMEDICAL CORPORATION
Nova
In Commercial Distribution

  • 00385480634120 ()
  • 10385480634127 ()
63412

  • Assay container IVD, single-use

QuickThaw® - 00816394020667

Plasma Thawing System
HELMER, INC.
DH2
In Commercial Distribution

  • 00816394020667 ()


  • Cryopreserved blood/tissue thawing unit

QuickThaw® - 00816394020650

Plasma Thawing System
HELMER, INC.
DH8
In Commercial Distribution

  • 00816394020650 ()


  • Cryopreserved blood/tissue thawing unit

QuickThaw® - 00816394020643

Plasma Thawing System
HELMER, INC.
DH4
In Commercial Distribution

  • 00816394020643 ()


  • Cryopreserved blood/tissue thawing unit

Immunoassay Plate Washer - 00816870020044

No Description
MONOBIND, INC.
IN002
In Commercial Distribution

  • 00816870020044 ()
IN002

  • Microplate washer IVD

NICO Myriad - 00816744028398

Specimen Infusion Valve (SIV) 0.760 mm ID Metering Line
NICO CORPORATION
NN-8039
In Commercial Distribution

  • 10816744028395 ()
  • 00816744028398 ()


  • Surgical suction system Y-piece valve-connector

NICO Myriad - 00816744028169

Specimen Infusion Valve (SIV) 0.5 mm Metering Line
NICO CORPORATION
NN-8016
In Commercial Distribution

  • 10816744028166 ()
  • 00816744028169 ()


  • Surgical suction system Y-piece valve-connector
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