FDA UDI In Commercial Distribution 🇺🇸 United States

cobas pro Sample Buffer

DI: 07613336159095 · Model: 08463689001 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
cobas pro Sample Buffer
Primary DI
07613336159095
Version / Model
08463689001
Catalog Number
08463689001
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-10
Public Version
2
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
cf673552-4158-4240-a764-f20f5562bd10

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

GMDN Terms

Code Name
58237 Buffered sample diluent IVD

Identifiers

Type ID
Primary 07613336159095