DxH 900 Hematology System

GUDID 15099590701574

UniCel DxH 900 Coulter Cellular Analysis System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD

• Primary Device ID: 15099590701574
• NIH Device Record Key: ea97262c-d4b5-44e3-80d8-f5bc2fb0a5a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH 900 Hematology System
• Version Model Number: C11478
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590701574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140911

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-05-03

Devices Manufactured by Beckman Coulter, Inc.

• 15099590772840 - Access Ferritin: 2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
• 15099590745158 - ACCESS HIV Ag/Ab combo: 2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi
• 15099590745165 - ACCESS HIV Ag/Ab combo Calibrators: 2024-03-25 The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitati
• 15099590745172 - ACCESS HIV Ag/Ab combo QC: 2024-03-25 The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV
• 15099590793005 - MicroScan: 2024-03-25 DVD, LabPro V4_V5 Maintenance Update 05
• 15099590780982 - Access Free T4: 2024-03-20 The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thy
• 15099590752682 - Access Progesterone II: 2024-03-11 The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of
• 15099590752699 - Access Progesterone II Calibrators: 2024-03-11 The Access Progesterone II Calibrators are intended to calibrate the Access Progesterone II assay for the quantitative determina