LH Slidemaker 6605633

GUDID 15099590330620

LH Slidemaker

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated
Primary Device ID15099590330620
NIH Device Record Keya3908d26-70e5-479e-99a7-bef56e32df91
Commercial Distribution StatusIn Commercial Distribution
Brand NameLH Slidemaker
Version Model Number6605633
Catalog Number6605633
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590330620 [Primary]

FDA Product Code

GKJSpinner, Slide, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

Devices Manufactured by Beckman Coulter, Inc.

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15099590763633 - Access Syphilis Calibrators2025-05-15 The Access Syphilis Calibrators are used to establish calibration (determine the cut-off value) for the Access Syphilis assay. B
15099590763640 - Access Syphilis QC2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for
05099590798218 - DxH2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
15099590209636 - DxH2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and

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