FDA UDI In Commercial Distribution 🇺🇸 United States

cobas® Liat® Strep A Script

DI: 07613336129692 · Model: 08085471001 · Roche Molecular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
cobas® Liat® Strep A Script
Primary DI
07613336129692
Version / Model
08085471001
Catalog Number
08085471001
Company Name
Roche Molecular Systems, Inc.
Labeler DUNS
071674100
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2022-04-15
Public Version Status
Update
Public Device Record Key
fe3550ee-d0a9-40ad-a40e-6a5e30935fb4

Device Characteristics

Single Use
Yes
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
Yes
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 07613336129692