Serodia TP-PA

GUDID 00850212007010

100 test kit

FUJIREBIO US, INC.

Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination

• Primary Device ID: 00850212007010
• NIH Device Record Key: 6b9bf974-4a88-401a-a0a7-ee35ac3a1809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serodia TP-PA
• Version Model Number: 1626
• Company DUNS: 029385775
• Company Name: FUJIREBIO US, 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: true
• Device Combination Product: false
• Single Use: false
• 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: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx
• Phone: 800-531-7963
• Email: xx@xx.xx

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

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850212007010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971502

FDA Product Code

• GMT: Antigens, Ha, Treponema Pallidum

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Serodia TP-PA]

• 00850212007027: 220 test kit
• 00850212007010: 100 test kit