FDA.reportPublic FDA data

ZBT-ESR

Primary DI
00860011967736
Brand
ZBT-ESR
Company
STERILE SAFEQUIP & CHEMICALS LLP
Model
21.ZBT10
Catalog number
ZBT10
Device description
Automated Erythrocyte sedimentation rate analyser
Published
2024-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GKBDevice, Automated Sedimentation Rate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKBDevice, Automated Sedimentation RateHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011967736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011967736008600119677368600119677360860011967736

GMDN Terms#

Term, Definition table
TermDefinition
Erthrocyte sedimentation rate (ESR) analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
876881873
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011967750ZELLECHEM 20033.ZCH01ZCH032024-10-01
00860011967743ZELLECHEM-PRO31.ZCH01ZCH012024-07-09
00860011967712ZELLESR-1011.ZE10ZE102024-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719189137781StarrsedMechatronics USA LLCGKB2024-08-26
00868556000208ESR STAT 6Airscan, Inc.GKB2024-06-04
08033891324551VES-MATIC ORIGINALDIESSE DIAGNOSTICA SENESE SPAGKB2023-12-14
00850028040041iSED EliteALCOR SCIENTIFIC INC.GKB2023-11-03
03661540300288Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300295Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300301Excyte® ESR Non-Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300318Excyte® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300325Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300332Excyte® ESR Vacuum Tube, CartonELITECHGROUP INC.GKB2023-10-01
03661540300035Microsed-System® Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300042Mix-Rate® X20 Automated ESR AnalyzerELITECHGROUP INC.GKB2023-10-01
03661540300202Monosed® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300219Monosed® ESR Vacuum Tubes, CartonELITECHGROUP INC.GKB2023-10-01
03661540300240Excyte® ESR Non-Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300257Excyte® ESR Vacuum TubesELITECHGROUP INC.GKB2023-10-01
03661540300264Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
03661540300271Excyte® ESR Vacuum TubeELITECHGROUP INC.GKB2023-10-01
08719189137132Starrsed Cleaning AgentRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137217Starrsed Rinse SolutionRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137224Starrsed X-CleanRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137231Starrsed DisinfectantRR Mechatronics Manufacturing B.V.GKB2023-07-25
08719189137200Starrsed SalineRR Mechatronics Manufacturing B.V.GKB2023-07-24
06936895301097BIOBASEBiobase Biodustry(Shandong)Co., Ltd.GKB2023-07-05
08719189137118Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137125Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137149Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137170Starrsed ControlRR Mechatronics Manufacturing B.V.GKB2022-12-05
08719189137286StarrsedMechatronics USA LLCGKB2022-12-05
08719189137293StarrsedMechatronics USA LLCGKB2022-12-05