Biokit RPR 500 TESTS

Basic Information

• Brand Name: Biokit RPR 500 TESTS
• Primary DI: 08426950592327
• Version / Model: 300625550
• Company Name: BIOKIT, S.A.
• Labeler DUNS: 460055742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 0611d9ed-bdb6-4075-9add-61daa7150e28

Device Description

3 x 3.0 ml RPR ANTIGEN 1 x 1.5 ml REACTIVE CONTROL 1 x 1.5 ml MODERATE REACTIVE CONTROL 1 x 1.5 ml NONREACTIVE CONTROL 50 disposable cards 500 dispensing / spreading pipettes 1 antigen dispensing vial 1 antigen dispensing needle

Device Characteristics

• Single Use: Yes
• 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: No
• 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
GMQ	Antigens, Nontreponemal, All	Microbiology	866.3820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51819	Treponema pallidum reagin antibody IVD, kit, agglutination	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema pallidum bacteria, in a clinical specimen using an agglutination method [for example Rapid Plasma Reagin (RPR) test or Venereal Disease Research Laboratory (VDRL) test]. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08426950592327	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K910541	000

Storage Conditions

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