PR 4100 91587

GUDID 03610520013571

PR 4100

BIO-RAD

Enzyme immunoassay (EIA) analyser IVD

• Primary Device ID: 03610520013571
• NIH Device Record Key: 9f45c7a0-5dab-4947-97da-25c6685dd4b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PR 4100
• Version Model Number: 91587
• Catalog Number: 91587
• Company DUNS: 269902602
• Company Name: BIO-RAD
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com
• Phone: +1(800)224-6723
• Email: TechSupport-Redmond@Bio-Rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03610520013571 [Primary]

FDA Product Code

• JJQ: COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-13
• Device Publish Date: 2023-02-03

Devices Manufactured by BIO-RAD

• 03610520002933 - Select: 2023-08-09 MRSASelect
• 03610520007860 - PLATELIA: 2023-08-09 PLATELIA Lyme IgM
• 03610520007877 - PLATELIA: 2023-08-09 PLATELIA Lyme IgG
• 03610522220519 - Platelia: 2023-07-11 Platelia SARS-CoV-2 Total Ab
• 03610522220526 - Platelia: 2023-07-11 Platelia SARS-CoV-2 Total Ab
• 03610520010785 - GEENIUS: 2023-02-13 Geenius Reader
• 03610520013328 - EVOLIS: 2023-02-13 EVOLIS
• 03610520013571 - PR 4100: 2023-02-13PR 4100
• 03610520013571 - PR 4100: 2023-02-13 PR 4100