FDA UDI In Commercial Distribution 🇺🇸 United States

CEDIA Antibiotic TDM Multi-Cal

DI: 00884883007116 · Model: 08777934 190 · Microgenics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CEDIA Antibiotic TDM Multi-Cal
Primary DI
00884883007116
Version / Model
08777934 190
Company Name
Microgenics Corporation
Labeler DUNS
122153799
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-20
Public Version
1
Public Version Date
2019-11-28
Public Version Status
New
Public Device Record Key
8cc81234-2767-4a85-ba02-d15395845a72

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
Yes
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
DKB Calibrators, Drug Mixture

GMDN Terms

Code Name
55234 Multiple-therapy therapeutic drug monitoring IVD, calibrator

Identifiers

Type ID
Primary 00884883007116