FDA UDI In Commercial Distribution 🇺🇸 United States

cobas Liat Strep A Script Version 1.27

DI: 07613336156544 · Model: 08403856001 · Roche Molecular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
cobas Liat Strep A Script Version 1.27
Primary DI
07613336156544
Version / Model
08403856001
Catalog Number
08403856001
Company Name
Roche Molecular Systems, Inc.
Labeler DUNS
071674100
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-17
Public Version
3
Public Version Date
2022-03-22
Public Version Status
Update
Public Device Record Key
9224fe76-cdff-4741-a14e-c7dad2c74f80

Device Characteristics

Single Use
No
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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
PGX Groups A, C and G beta-hemolytic streptococcus nucleic acid amplification system

GMDN Terms

Code Name
43472 Laboratory instrument/analyser application software IVD

Identifiers

Type ID
Primary 07613336156544