FDA UDI In Commercial Distribution 🇺🇸 United States

Syva® RapidTest d.a.u.® MDN

DI: 00842768001260 · Model: 10445354 · Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25

Basic Information

Brand Name
Syva® RapidTest d.a.u.® MDN
Primary DI
00842768001260
Version / Model
10445354
Catalog Number
6A109UL
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
07a7de75-2459-4f49-90e5-3b31d48c740c

Device Description

Syva® RapidTest d.a.u.® Methadone MDN

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
DJR ENZYME IMMUNOASSAY, METHADONE

GMDN Terms

Code Name
30521 Methadone IVD, kit, rapid ICT, clinical

Identifiers

Type ID
Primary 00842768001260
Unit of Use 00630414013862

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
2 – 30 Degrees Celsius