FDA UDI In Commercial Distribution 🇺🇸 United States

CHOLESTEROL HDL 2G CALIBRATOR

DI: 03701700821403 · Model: HDLL-0041 · VITALSCIENTIFIC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CHOLESTEROL HDL 2G CALIBRATOR
Primary DI
03701700821403
Version / Model
HDLL-0041
Company Name
VITALSCIENTIFIC
Labeler DUNS
267732378
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-03-31
Public Version
1
Public Version Date
2025-04-08
Public Version Status
New
Public Device Record Key
ae3b432e-def6-4f91-862c-a14a170f337f

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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

GMDN Terms

Code Name
44696 High density lipoprotein (HDL) cholesterol IVD, calibrator

Identifiers

Type ID
Primary 03701700821403