Quantase 5325040

GUDID 00847817021527

Quantase Neonatal Accessory Kit 5 Elution Buffer

BIO-RAD LABORATORIES, INC.

Glycated haemoglobin (HbA1c) IVD, reagent

• Primary Device ID: 00847817021527
• NIH Device Record Key: 3a2ed249-0de9-4014-b61a-85121137fc6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantase
• Version Model Number: 532-5040
• Catalog Number: 5325040
• Company DUNS: 132528295
• Company Name: BIO-RAD LABORATORIES, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817021527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963040

FDA Product Code

• JNB: NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-12

Devices Manufactured by BIO-RAD LABORATORIES, INC.

• 00847661004080 - Quest Diagnostics: 2023-10-17 Quest Diagnostics Tumor Marker Control (A human serum tumor marker control.)
• 03610520540916 - Quest Diagnostics: 2023-10-17 Quest Diagnostics Immunoassay/TDM Control (A human serum immunoassay/TDM control.)
• 03610520540923 - Quest Diagnostics: 2023-10-17 Quest Diagnostics Serum Chemistry Control Trilevel (A human serum chemistry control.)
• 03610520540930 - Quest Diagnostics: 2023-10-17 Quest Diagnostics Serum Chemistry Control Trilevel (A human serum chemistry control.)
• 03610521168942 - Geenius: 2023-08-07 Geenius HIV 1/2 Supplemental Assay 20t
• 03610522162239 - Geenius: 2023-08-07 Geenius Blood Donor IFU & APF v2.0 binder
• 03610522162260 - Geenius: 2023-08-07 Geenius Software V2.0 LIS Guide, US only
• 03610522168064 - Geenius: 2023-08-07 Geenius SW V2.0 & APF V2.0 Installation Kit