FDA UDI In Commercial Distribution 🇺🇸 United States

cobas® CMV

DI: 00875197006421 · Model: 09040897190 · Roche Molecular Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
cobas® CMV
Primary DI
00875197006421
Version / Model
09040897190
Catalog Number
09040897190
Company Name
Roche Molecular Systems, Inc.
Labeler DUNS
071674100
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-12-10
Public Version
1
Public Version Date
2021-12-22
Public Version Status
New
Public Device Record Key
e3b5c7ed-1358-4071-864f-56a0e73122e7

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
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
PAB Cytomegalovirus (cmv) dna quantitative assay

GMDN Terms

Code Name
30798 Cytomegalovirus (CMV) nucleic acid IVD, kit, nucleic acid technique (NAT)

Identifiers

Type ID
Primary 00875197006421