FDA.reportPublic FDA data

QBC Diagnostics

Primary DI
00858092006611
Brand
QBC Diagnostics
Company
DRUCKER DIAGNOSTICS
Model
429002
Catalog number
429002
Device description
Straight-Repaired QBC STAR-I Centrifugal Hematology System: QBC STAR-I Analyzer; QBC Disposable Starter Kit (20 STAR Tubes)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992849000QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1999-09-23GKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858092006628Direct MarkingGS10
00858092006611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858092006628008580920066288580920066280858092006628
00858092006611008580920066118580920066110858092006611

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

Regulatory Flags#

DUNS number
022156957
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810052864990Boost 2 Flex DC Centrifuge, Revance00-876-141-00000-876-141-0002026-05-11
00810052865003Boost 4 Centrifuge, Pointiva Medical00-289-303-00000-289-303-0002026-05-11
00810052864983DASH Pro 24 Centrifuge, Drucker00-784-009-00000-784-009-0002026-05-04
00810052864976TrueBond TriFLEX Centrifuge, Pivetal00-389-256-00000-389-256-0002026-04-29
00810052864396DASH Coag Centrifuge, Boekel, Tall Rotor00-676-260-00100-676-260-0012024-08-08
00810052864051SERO 12 Centrifuge, Boekel, Pop Up Lid00-483-260-00100-483-260-0012023-12-14
00810052863726Horizon 24 Flex Centrifuge, Boekel00-384-260-00000-384-260-0002023-06-26
00810052863733Horizon 12 Flex Centrifuge, Boekel00-383-260-00000-383-260-0002023-06-26
00810052863689Horizon 6 Flex FA Centrifuge, Boekel00-376-260-00100-376-260-0012023-06-22
00810052863702SERO 12 Centrifuge, Boekel00-483-260-00000-483-260-0002023-06-22
00810052863719Horizon 6 Flex Centrifuge, Boekel00-376-260-00000-376-260-0002023-06-22
00810052863665DASH Flex 12 Centrifuge, Boekel00-183-260-00000-183-260-0002023-06-20
00810052863672DASH Flex 24 Centrifuge, Boekel00-184-260-00000-184-260-0002023-06-20
00810052863658642M Centrifuge, Boekel00-077-260-00000-077-260-0002023-06-19
00810052863641642E Centrifuge, Boekel00-018-260-00000-018-260-0002023-06-16
00810052863634642B Centrifuge, Boekel00-016-260-00000-016-260-0002023-06-15
00810052863016DASH Flex 24 Centrifuge, Royal Biologics00-184-005-00000-184-005-0002026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal Biologics00-184-005-00100-184-005-0012026-03-25
00810052864945642M Centrifuge, AccuReference00-077-241-00000-077-241-0002026-02-02
00810052864938TrueBond Set 3 Centrifuge, Zoetis00-276-226-00000-276-226-0002026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860008385871Athelas HomeAthelas, Inc.GKZ2026-04-27
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
00850063751216CitoCBC CartridgeCYTOCHIP INCGKZ2025-07-01
06944904002422BC-3200 Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.GKZ2025-01-17
04987562508440XQ-520 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2025-01-14
03610230009444Yumizen H2500HORIBA ABX SASGKZ2024-11-29
03610230009451Yumizen H2500HORIBA ABX SASGKZ2024-11-29
15099590762889Stem-Kit ReagentsBeckman Coulter, Inc.GKZ2024-10-25
15099590762896StemTrol Control CellsBeckman Coulter, Inc.GKZ2024-10-25
07290016991086HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2024-09-02
04987562503131XQ-320 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2024-05-24
00380740138851AlinityABBOTT LABORATORIESGKZ2023-11-16
00382906643438BD Trucount™Becton, Dickinson And CompanyGKZ2023-08-07
00382906654212FACSDivaBecton, Dickinson And CompanyGKZ2022-10-12
20860008385868Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29
07290016991079HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
17290016991076HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
08809317540993ADAM-rWBC HTNanoEnTek, Inc.GKZ2021-02-15
08809317541006ADAM-rWBC KitNanoEnTek, Inc.GKZ2021-02-15
08809317540627ADAMIINanoEnTek, Inc.GKZ2020-09-02
08809317540634ADAMII-CD34 KitNanoEnTek, Inc.GKZ2020-09-02
15099590671242DxH 500BECKMAN COULTER IRELAND INC.GKZ2020-08-31
15099590729110UniCel DxH 690T Coulter Cellular Analysis System Beckman Coulter, Inc.GKZ2020-08-31