Syva® RapidTest d.a.u.® 10

Basic Information

• Brand Name: Syva® RapidTest d.a.u.® 10
• Primary DI: 00842768001345
• Version / Model: 10445363
• Catalog Number: 6A289UL
• 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: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 9dcbe235-d6fd-4d3e-ac17-8aa03d56d6b1

Device Description

Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP

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
LFI	HIGH PRESSURE LIQUID CHROMATOGRAPHY, TRICYCLIC ANTIDEPRESSANT DRUGS	Clinical Toxicology	862.3910	2
LCM	Enzyme immunoassay, phencyclidine	Unknown		U
DJR	ENZYME IMMUNOASSAY, METHADONE	Clinical Toxicology	862.3620	2
LAG	HIGH PRESSURE LIQUID CHROMATOGRAPHY, METHAMPHETAMINE	Clinical Toxicology	862.3610	2
DKE	REAGENTS, TEST, TETRAHYDROCANNABINOL	Clinical Toxicology	862.3870	2
DIS	ENZYME IMMUNOASSAY, BARBITURATE	Clinical Toxicology	862.3150	2
DIO	ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES	Clinical Toxicology	862.3250	2
DJG	ENZYME IMMUNOASSAY, OPIATES	Clinical Toxicology	862.3650	2
DKN	RADIOIMMUNOASSAY, BARBITURATE	Clinical Toxicology	862.3150	2
DKZ	ENZYME IMMUNOASSAY, AMPHETAMINE	Clinical Toxicology	862.3100	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
Primary	00842768001345	GS1
Unit of Use	00630414013978	GS1

Customer Contacts

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

Storage Conditions

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