STATSWAB®

Basic Information

• Brand Name: STATSWAB®
• Primary DI: 00816036028501
• Version / Model: SSB-148
• Catalog Number: SSB-148
• Company Name: MICRO DISTRIBUTING, L.C
• Labeler DUNS: 087732173
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-11-04
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 7dec1f11-ac04-45d9-943a-910f116e6a43

Device Description

STATSWAB saliva device, 25Pcs/Box COC/mAMP/OPI/THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3650	2
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3870	2
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3250	2
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00816036029003	GS1
Primary	00816036028501	GS1

Customer Contacts

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