Syphilis Control

Basic Information

• Brand Name: Syphilis Control
• Primary DI: 00850212007065
• Version / Model: 2130170
• Company Name: FUJIREBIO DIAGNOSTICS, INC.
• Labeler DUNS: 079291908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-23
• Public Version: 3
• Public Version Date: 2020-07-15
• Public Version Status: Update
• Public Device Record Key: 1a7d6d2a-aead-45f3-a7da-17a650ebfa62

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37733	Treponema pallidum total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum bacteria in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850212007065	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size Type = Units per Kit; Units = 6; Unit of Measure = 4.5mLs

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius