Syva® RapidTest d.a.u.® OPI

Basic Information

• Brand Name: Syva® RapidTest d.a.u.® OPI
• Primary DI: 00842768001215
• Version / Model: 10445349
• Catalog Number: 6A049UL
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 64554795-1d3d-4514-80cb-a00dc6c369c9

Device Description

Syva® RapidTest d.a.u.® Opiates OPI

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: 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
DJG	ENZYME IMMUNOASSAY, OPIATES	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30522	Opiate/opiate metabolite 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 opiate and/or opiate metabolites 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	00842768001215	GS1
Unit of Use	00630414013824	GS1

Customer Contacts

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

Storage Conditions

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