RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50)

Basic Information

• Brand Name: RAPID DIAGNOSTICS M-AMPHAMPHETAMINE TEST STRIP KIT (50)
• Primary DI: 00817830020142
• Version / Model: 07RD8005
• Catalog Number: 07RD8005
• Company Name: RAPID DIAGNOSTICS INC
• Labeler DUNS: 008028248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-24
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: ecd9541b-f2b5-4e81-9518-d0be873b2c42

Device Description

M-AMPHAMPHETAMINE TEST STRIP KIT (50)

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
DJC	Thin layer chromatography, methamphetamine	Clinical Toxicology	862.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55498	Methamphetamine-specific 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 a specific methamphetamine 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
Primary	00817830020142	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	72	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius