FDA.reportPublic FDA data

QBC Diagnostics

Primary DI
00858092006543
Brand
QBC Diagnostics
Company
DRUCKER DIAGNOSTICS
Model
424305
Catalog number
424305
Device description
QBC Extended Range Hematology Controls
Published
2016-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JPKMixture, Hematology Quality Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPKMixture, Hematology Quality ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984099000QBC CENTRIFUGAL HEMATOLOGY CONTROLR&D Systems, Inc.1998-12-10JPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858092006543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858092006543008580920065438580920065430858092006543

GMDN Terms#

Term, Definition table
TermDefinition
Full blood count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count, and calculation of red cell parameters and/or platelet count, as well as other general blood evaluation tests [e.g., C-reactive protein (CRP)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022156957
Device count
1
Lot or batch
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
Primary DIBrandCompanyProduct codePublished
00860015924209ST 201 Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924216ST 201-B Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00860015924223ST 201-C Fetal Hemoglobin ControlSURE-TECH DIAGNOSTIC ASSOCIATES, INC.JPK2026-05-19
00630414290058Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290065Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290072Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290089Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290096Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290102Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290119Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414290126Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323640Atellica HEMA Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323657Atellica HEMA Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323534Atellica HEMA Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323541Atellica HEMA Retic Control (L)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323558Atellica HEMA Retic Control (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323565Atellica HEMA Retic Control (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323572Atellica HEMA Control BF (N)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00630414323589Atellica HEMA Control BF (H)Siemens Healthcare Diagnostics Inc.JPK2026-02-06
00860001900538IntelliSep Quality Control KitCytovale IncJPK2025-07-03
00815762026362Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-06
00815762026508Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.JPK2025-06-04
03610230008584BFTROLHORIBA ABX SASJPK2024-09-26
03610230009581ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009598ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
03610230009604ABX Minotrol 16HORIBA ABX SASJPK2024-09-25
00868556000215HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000239HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000246HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04
00868556000253HemaTechnologies ESR ControlAirscan, Inc.JPK2024-06-04