QBC Diagnostics 253005

GUDID 00858092006475

Malaria Tube - Blood Collection Device (2000 Test Kit)

DRUCKER DIAGNOSTICS

Capillary blood collection tube, no additive
Primary Device ID00858092006475
NIH Device Record Key8e78e630-f64d-42a8-83af-a6eb2e7bad9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameQBC Diagnostics
Version Model Number253005
Catalog Number253005
Company DUNS022156957
Company NameDRUCKER DIAGNOSTICS
Device Count2000
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858092006338 [Unit of Use]
GS100858092006475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-09
Device Publish Date2016-09-24

On-Brand Devices [QBC Diagnostics]

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00858092006642Straight-Repaired Original QBC STAR Centrifugal Hematology System: Original QBC STAR Analyzer; Q
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00858092006598Venous Tube - Blood Collection Device (Starter Kit)
00858092006581Capillary Tube - Blood Collection Device (Starter Kit)
00858092006574AccuTube - Blood Collection Device (Starter Kit)
00858092006567Refurbished QBC STAR-I Centrifugal Hematology System, Biochem: Refurbished QBC STAR-I Analyzer -
00858092006550QBC STAR-I Centrifugal Hematology System, Biochem: QBC STAR-I Analyzer - Biochem; QBC Disposable
00858092006543QBC Extended Range Hematology Controls
00858092006536Mobile Power Station
00858092006529ParaLens Advance Optilume Light Source Upgrade Kit
00858092006512ParaLens Advance Portability Pack
00858092006475Malaria Tube - Blood Collection Device (2000 Test Kit)
00858092006468Malaria Tube - Blood Collection Device (250 Tube Box); Inner Labeled Package of Malaria 2000 Tes
00858092006451Malaria Tube - Blood Collection Device (100 Test Kit)
00858092006444Capillary Tube - Blood Collection Device (1000 Test Kit)
00858092006437Capillary Tube - Blood Collection Device (200 Tube Box); Inner Labeled Package of Capillary 1000
00858092006420Capillary Tube - Blood Collection Device (100 Test Kit)
00858092006413Venous Tube - Blood Collection Device (1000 Test Kit)
00858092006406Venous Tube - Blood Collection Device (200 Tube Box); Inner Labeled Package of Venous 1000 Test
00858092006390Venous Tube - Blood Collection Device (100 Test Kit)
00858092006383AccuTube - Blood Collection Device (100 Test Kit)
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00858092006321ParaLens Advance with 20X, 40X, & 100X Objectives
00858092006314ParaLens Advance with 40X & 100X Objectives
00858092006291QBC STAR Tube - Blood Collection Tube (Box of 100)
00858092006277QBC Hematology Controls
00858092006260Refurbished QBC Autoread Plus Analyzer System with Accessories but without Centrifuge
00858092006253Refurbished QBC Autoread Plus System - Dry Hematology Analyzer and Capillary Tube Centrifuge
00858092006246QBC Malaria Test System - ParaLens Advance with 60X Objective and Capillary Centrifuge
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00858092006215QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (1
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00858092006192QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives, Microscope, and
00858092006161QBC ParaLens Advance with 10X, 20X, 40X, & 100X Objectives, & Infinity Corrective Lens
00858092006154QBC ParaLens Advance with 20X, 40X, 60X, & 100X Objectives, and Portability Pack
00858092006147QBC ParaLens Advance with 100X Objective
00858092006130QBC ParaLens Advance with 60X Objective
00858092006123QBC ParaLens Advance with 20X & 40X Objectives
00858092006116QBC F.A.S.T. Malaria Stain 1 Gallon Bottle
00858092006109QBC F.A.S.T. Malaria Stain 250 mL Bottle
00858092006093QBC F.A.S.T. Malaria Stain 120 mL Bottle
00858092006086Refurbished QBC Autoread Plus Dry Hematology Analyzer
00858092006079Refurbished QBC Autoread Plus Instrument, Human, Domestic
00858092006062Refurbished QBC Centrifuge - Capillary Tube Centrifuge
00858092006055Refurbished QBC STAR-M Centrifugal Hematology System: Refurbished QBC STAR-M Analyzer; QBC Dispo
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