StrepPRO™

Basic Information

• Brand Name: StrepPRO™
• Primary DI: 00819398027922
• Version / Model: PL038HD
• Catalog Number: PL038HD
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-02
• Public Version: 1
• Public Version Date: 2020-09-10
• Public Version Status: New
• Public Device Record Key: 40e9a3c1-58ee-47b3-b8dc-9a137e7ddb95

Device Description

StrepPRO™ Extraction Reagent 2, for the rapid latex agglutination test, 60 tests, Extraction 2 Reagent for the rapid latex agglutination test for the identification of streptococcal groups.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
GTZ	Antisera, All Groups, Streptococcus Spp.	Microbiology	866.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43730	Beta-haemolytic Streptococcus serological grouping IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027922	GS1

Customer Contacts

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

Storage Conditions

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