STA® - Staclot® dRVV Screen 2

Basic Information

• Brand Name: STA® - Staclot® dRVV Screen 2
• Primary DI: 13607450003397
• Version / Model: 00339
• Company Name: DIAGNOSTICA STAGO
• Labeler DUNS: 262277122
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 4
• Public Version Date: 2021-04-12
• Public Version Status: Update
• Public Device Record Key: 12bb32f5-e5b1-4239-a08e-e52b5199b3b0

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
GIR	REAGENT, RUSSEL VIPER VENOM	Hematology	864.8950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56202	Lupus anticoagulant marker IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	13607450003397	GS1
Unit of Use	03607450003390	GS1

Premarket Submissions

Submission Number	Supplement Number
K061805	000

Storage Conditions

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