FDA UDI In Commercial Distribution 🇺🇸 United States

Tumor Marker Control level 1

DI: 00817238010110 · Model: 91301 · CLINIQA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Tumor Marker Control level 1
Primary DI
00817238010110
Version / Model
91301
Company Name
CLINIQA CORPORATION
Labeler DUNS
078742335
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-22
Public Version
3
Public Version Date
2020-12-21
Public Version Status
Update
Public Device Record Key
799c01db-c357-4066-9dda-b9a41b8ad3db

Device Description

Tumor Marker Control level 1

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
JJY Multi-Analyte Controls, All Kinds (Assayed)

GMDN Terms

Code Name
47869 Multiple-type clinical chemistry analyte profile IVD, control

Identifiers

Type ID
Primary 00817238010110