VARIANT II B-thalassemia 2700004

GUDID 00847817008610

VARIANT II B-thalassemia Short Program Elution Buffer 1

BIO-RAD LABORATORIES, INC.

Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent Haemoglobin F (HbF) IVD, reagent

• Primary Device ID: 00847817008610
• NIH Device Record Key: e542d9b1-1d25-49ed-ae88-ec4afc6b498f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARIANT II B-thalassemia
• Version Model Number: 270-0004
• Catalog Number: 2700004
• 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
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com
• Phone: +1(800)224-6723
• Email: diagcs@bio-rad.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847817008610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991127

FDA Product Code

• JPD: HEMOGLOBIN A2 QUANTITATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-09-12

On-Brand Devices [VARIANT II B-thalassemia]

• 00847817012303: VARIANT II B-thalassemia Short Program Wash/Diluent Solution
• 00847817009914: VARIANT II B-thalassemia Short Program Analytical Cartridge
• 00847817009204: VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set
• 00847817008634: VARIANT II B-thalassemia Short Program Elution Buffer 2
• 00847817008610: VARIANT II B-thalassemia Short Program Elution Buffer 1
• 00847817000805: VARIANT II B-Thalassemia Short Program Reorder Pack
• 00847817000447: VARIANT II B-thalassemia Short Program Reorder Pack