Hemolysis and Wash Solution

GUDID 00853931008030

Red Cell Lysing Reagent

TOSOH BIOSCIENCE, INC.

Buffered wash solution IVD, automated/semi-automated system Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD

• Primary Device ID: 00853931008030
• NIH Device Record Key: 7ca72db7-ca96-42bc-9d73-f446bc3bb06a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemolysis and Wash Solution
• Version Model Number: 018431US
• Company DUNS: 607696440
• Company Name: TOSOH BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com
• Phone: 614-317-1916
• Email: kimberly.harmeson@tosoh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853931008030 [Primary]

FDA Product Code

• GGK: Products, Red-Cell Lysing Products

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-06-08
• Device Publish Date: 2018-04-23

Devices Manufactured by TOSOH BIOSCIENCE, INC.

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• 00853931008016 - Glycated Hemoglobin (HbA1C) Analyzer IVD: 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured
• 00853931008023 - Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured: 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 290 Sample Loader, Remanufactured
• 00853931008030 - Hemolysis and Wash Solution: 2018-06-08Red Cell Lysing Reagent
• 00853931008030 - Hemolysis and Wash Solution: 2018-06-08 Red Cell Lysing Reagent