FDA.reportPublic FDA data

QBC Diagnostics

Primary DI
00858092006215
Brand
QBC Diagnostics
Company
DRUCKER DIAGNOSTICS
Model
427420
Catalog number
427420
Device description
QBC F.A.S.T. AFB Detection System - ParaLens Advance with 20X & 40X Objectives and Centrifuge (115V)
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
GKBDevice, Automated Sedimentation Rate
JSYKit, Identification, Mycobacteria

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1
JSYKit, Identification, MycobacteriaMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858092006215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858092006215008580920062158580920062150858092006215

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain kit IVDA collection of chemical agents, dyes and/or solutions intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen for subsequent visualization, examination, identification and/or differentiation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022156957
Device count
1
Kit
true
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

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