FDA UDI In Commercial Distribution 🇺🇸 United States

cobas® TaqScreen MPX Test, v2.0

DI: 00875197004045 · Model: 2.0 · Roche Molecular Systems, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
cobas® TaqScreen MPX Test, v2.0
Primary DI
00875197004045
Version / Model
2.0
Catalog Number
05969484190
Company Name
Roche Molecular Systems, Inc.
Labeler DUNS
071674100
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-02-20
Public Version
3
Public Version Date
2021-02-03
Public Version Status
Update
Public Device Record Key
084e8c12-140a-4eaf-8f03-4a206486da75

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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

GMDN Terms

Code Name
48216 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Identifiers

Type ID
Primary 00875197004045