InteliQ 12009948

GUDID 03610522114184

InteliQ Immunoassay Plus Control Level 1 (A human serum assayed immunoassay and TDM control.)

BIO-RAD LABORATORIES, INC.

Multiple clinical chemistry protein IVD, control
Primary Device ID03610522114184
NIH Device Record Key710ece43-5017-47df-bf32-16b030e7132c
Commercial Distribution StatusIn Commercial Distribution
Brand NameInteliQ
Version Model Number12009948
Catalog Number12009948
Company DUNS051624070
Company NameBIO-RAD LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com
Phone+1(800)854-6737
Emailqsd.techservice@bio-rad.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius
Storage Environment TemperatureBetween -70 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103610522114184 [Primary]

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-07
Device Publish Date2020-12-30

On-Brand Devices [InteliQ]

03610522114436InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers
03610522114429InteliQ Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers
03610522114412InteliQ Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers
03610522114405InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers c
03610522114399InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers c
03610522114382InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers c
03610522114375InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control.
03610522114368InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control.
03610522114351InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control.
03610522114344InteliQ Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.)
03610522114337InteliQ Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.)
03610522114320InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)
03610522113873InteliQ Immunology Control MiniPak (A human serum assayed protein control.)
03610522113866InteliQ Immunology Control Level 3 (A human serum assayed protein control.)
03610522113859InteliQ Immunology Control Level 2 (A human serum assayed protein control.)
03610522113842InteliQ Immunology Control Level 1 (A human serum assayed protein control.)
03610522046171InteliQ Ethanol/Ammonia Control MiniPak (An assayed ethanol and ammonia control.)
03610522046164InteliQ Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.)
03610522046157InteliQ Ethanol/Ammonia Control Level 2 (An assayed ethanol and ammonia control.)
03610522046140InteliQ Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.)
03610522046072InteliQ Tumor Marker Control MiniPak (A human based assayed tumor marker control.)
03610522046065InteliQ Tumor Marker Control Level 3 (A human based assayed tumor marker control.)
03610522046058InteliQ Tumor Marker Control Level 2 (A human based assayed tumor marker control.)
03610522046041InteliQ Tumor Marker Control Level 1 (A human based assayed tumor marker control.)
03610522045952InteliQ Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)
03610522045945InteliQ Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
03610522045938InteliQ Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)
03610522045921InteliQ Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)
03610522045914InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.)
03610522045846InteliQ Assayed Multiqual Control MiniPak (A human serum assayed chemistry control.)
03610522045839InteliQ Assayed Multiqual Control Level 3 (A human serum assayed chemistry control.)
03610522045822InteliQ Assayed Multiqual Control Level 2 (A human serum assayed chemistry control.)
03610522045815InteliQ Assayed Multiqual Control Level 1 (A human serum assayed chemistry control.)
03610520267233InteliQ Homocysteine Control MiniPak (A human serum assayed homocysteine control.)
03610520267226InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.)
03610520267219InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.)
03610520242582InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.)
03610522115969InteliQ Urine Chemistry Control Level 2 (A human urine assayed chemistry control.)
03610522115952InteliQ Urine Chemistry Control Level 1 (A human urine assayed chemistry control.)
03610522115945InteliQ Urine Chemistry Control Bilevel MiniPak (A human urine assayed chemistry control.)
03610522114214InteliQ Immunoassay Plus Control MiniPak (A human serum assayed immunoassay and TDM control.)
03610522114207InteliQ Immunoassay Plus Control Level 3 (A human serum assayed immunoassay and TDM control.)
03610522114191InteliQ Immunoassay Plus Control Level 2 (A human serum assayed immunoassay and TDM control.)
03610522114184InteliQ Immunoassay Plus Control Level 1 (A human serum assayed immunoassay and TDM control.)
03610522046270InteliQ Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
03610522046263InteliQ Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
03610522046256InteliQ Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
03610522046249InteliQ Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
03610522354665InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay
03610522231508InteliQ Specialty Immunoassay Plus Control Trilevel MiniPak (A human serum assayed immunoassay c

Trademark Results [InteliQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTELIQ
INTELIQ
87922749 not registered Live/Pending
BIO-RAD LABORATORIES, INC.
2018-05-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.