FDA.reportPublic FDA data

QBC Diagnostics

Primary DI
00858092006413
Brand
QBC Diagnostics
Company
DRUCKER DIAGNOSTICS
Model
424237
Catalog number
424237
Device description
Venous Tube - Blood Collection Device (1000 Test Kit)
Published
2016-09-24
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
GIOTube, Collection, Capillary Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858092006413PrimaryGS10
00858092006369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858092006413008580920064138580920064130858092006413
00858092006369008580920063698580920063690858092006369

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube, no additiveA non-sterile glass or plastic collection tube containing no additive, intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection, This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022156957
Device count
1000
Premarket exempt
true
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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