FDA UDI In Commercial Distribution 🇺🇸 United States

APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)

DI: 05055273209105 · Model: LE5016 · RANDOX LABORATORIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
APOLIPOPROTEIN CONTROL - LEVEL 1 (APO CONTROL 1)
Primary DI
05055273209105
Version / Model
LE5016
Company Name
RANDOX LABORATORIES LIMITED
Labeler DUNS
227530649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-06-03
Public Version
1
Public Version Date
2019-06-11
Public Version Status
New
Public Device Record Key
6da7d167-ef86-436e-b4a3-7d58c799a541

Device Characteristics

Single Use
Yes
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
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
JJY Multi-Analyte Controls, All Kinds (Assayed)

GMDN Terms

Code Name
43708 Multiple apolipoprotein IVD, control

Identifiers

Type ID
Primary 05055273209105