STA® - Reptilase®

Basic Information

• Brand Name: STA® - Reptilase®
• Primary DI: 13607450006145
• Version / Model: 00614
• Company Name: DIAGNOSTICA STAGO
• Labeler DUNS: 262277122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2021-04-08
• Public Version Status: Update
• Public Device Record Key: 445c18c7-8d06-4fb8-9eaa-f70106e63c85

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
JCO	BOTHROPS ATROX REAGENT	Hematology	864.8100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55989	Reptilase time IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the reptilase time of a clinical specimen, also known as batroxobin time, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	13607450006145	GS1
Unit of Use	03607450006148	GS1

Premarket Submissions

Submission Number	Supplement Number
K840210	000

Storage Conditions

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