Spirochete

Basic Information

• Brand Name: Spirochete
• Primary DI: 00847627002075
• Version / Model: API135AA
• Company Name: BIOCARE MEDICAL LLC
• Labeler DUNS: 806617825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-05-01
• Public Version Status: Update
• Public Device Record Key: 0085e705-de32-45a6-9324-2323bf151e03

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
MTN	Test, Syphilis, Treponemal	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
63935	Treponema pallidum antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of antigens from 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	00847627002075	GS1

Storage Conditions

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