FDA.reportPublic FDA data

QBC Diagnostics

Primary DI
00858092006628
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
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022156957
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
Primary DIBrandCompanyProduct codePublished
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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