FDA UDI In Commercial Distribution 🇺🇸 United States

InteliQ

DI: 03610522114375 · Model: 12009960 · BIO-RAD LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
InteliQ
Primary DI
03610522114375
Version / Model
12009960
Catalog Number
12009960
Company Name
BIO-RAD LABORATORIES, INC.
Labeler DUNS
051624070
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-02
Public Version
2
Public Version Date
2023-01-31
Public Version Status
Update
Public Device Record Key
f9a9b4bd-9f6f-48f6-b2de-c6fb8067cf4e

Device Description

InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.)

Device Characteristics

Single Use
Yes
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
JJY Multi-analyte controls, all kinds (assayed)

GMDN Terms

Code Name
47016 Multiple cardiac marker IVD, control

Identifiers

Type ID
Primary 03610522114375

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-70 – -20 Degrees Celsius