FDA UDI In Commercial Distribution 🇺🇸 United States

gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz

DI: 04015630925018 · Model: 5168775190 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
Primary DI
04015630925018
Version / Model
5168775190
Catalog Number
5168775190
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-01-18
Public Version
2
Public Version Date
2023-07-06
Public Version Status
Update
Public Device Record Key
0322080d-6f8f-4396-be79-157e441e8ff6

Device Characteristics

Single Use
Yes
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
Yes
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
JQB KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

GMDN Terms

Code Name
53027 Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

Identifiers

Type ID
Primary 04015630925018