FDA UDI In Commercial Distribution 🇺🇸 United States

DRUGS OF ABUSE LEVEL CAL 2

DI: B800DAUC2FNHI0 · Model: DAU C 2 F NHI · UTAK LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
DRUGS OF ABUSE LEVEL CAL 2
Primary DI
B800DAUC2FNHI0
Version / Model
DAU C 2 F NHI
Catalog Number
DAU C 2 F NHI
Company Name
UTAK LABORATORIES, INC.
Labeler DUNS
092519016
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-20
Public Version
1
Public Version Date
2023-07-28
Public Version Status
New
Public Device Record Key
65ef3358-7497-4421-9ef2-c5923ebeeb5e

Device Description

DRUGS OF ABUSE LEVEL CAL 2

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
LAS Drug Specific Control Materials

GMDN Terms

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

Identifiers

Type ID
Package B800DAUC2FNHI5
Primary B800DAUC2FNHI0

Customer Contacts

Device Sizes

Type Value Unit Text
Total Volume 1 Milliliter

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
– -10 Degrees Celsius