InteliQ 12008312
GUDID 03610522046270
InteliQ Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
Glycated haemoglobin (HbA1c) IVD, control| Primary Device ID | 03610522046270 |
| NIH Device Record Key | 4e89252b-de2a-4fe6-b721-d121dac7b4ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InteliQ |
| Version Model Number | 12008312 |
| Catalog Number | 12008312 |
| Company DUNS | 051624070 |
| Company Name | BIO-RAD LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com | |
| Phone | +1(800)854-6737 |
| qsd.techservice@bio-rad.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between -70 Degrees Celsius and -20 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03610522046270 [Primary] |
FDA Product Code
| GGM | Control, hemoglobin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-10 |
| Device Publish Date | 2021-04-30 |
On-Brand Devices [InteliQ]
| 03610522114436 | InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers |
| 03610522114429 | InteliQ Cardiac Markers Plus Control LT Level 1B MiniPak (A human serum assayed cardiac markers |
| 03610522114412 | InteliQ Cardiac Markers Plus Control LT Level 1A MiniPak (A human serum assayed cardiac markers |
| 03610522114405 | InteliQ Cardiac Markers Plus Control LT Level 3 MiniPak (A human serum assayed cardiac markers c |
| 03610522114399 | InteliQ Cardiac Markers Plus Control LT Level 2 MiniPak (A human serum assayed cardiac markers c |
| 03610522114382 | InteliQ Cardiac Markers Plus Control LT Level 1 MiniPak (A human serum assayed cardiac markers c |
| 03610522114375 | InteliQ Cardiac Markers Plus Control LT Level 1C (A human serum assayed cardiac markers control. |
| 03610522114368 | InteliQ Cardiac Markers Plus Control LT Level 1B (A human serum assayed cardiac markers control. |
| 03610522114351 | InteliQ Cardiac Markers Plus Control LT Level 1A (A human serum assayed cardiac markers control. |
| 03610522114344 | InteliQ Cardiac Markers Plus Control LT Level 3 (A human serum assayed cardiac markers control.) |
| 03610522114337 | InteliQ Cardiac Markers Plus Control LT Level 2 (A human serum assayed cardiac markers control.) |
| 03610522114320 | InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.) |
| 03610522113873 | InteliQ Immunology Control MiniPak (A human serum assayed protein control.) |
| 03610522113866 | InteliQ Immunology Control Level 3 (A human serum assayed protein control.) |
| 03610522113859 | InteliQ Immunology Control Level 2 (A human serum assayed protein control.) |
| 03610522113842 | InteliQ Immunology Control Level 1 (A human serum assayed protein control.) |
| 03610522046171 | InteliQ Ethanol/Ammonia Control MiniPak (An assayed ethanol and ammonia control.) |
| 03610522046164 | InteliQ Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.) |
| 03610522046157 | InteliQ Ethanol/Ammonia Control Level 2 (An assayed ethanol and ammonia control.) |
| 03610522046140 | InteliQ Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.) |
| 03610522046072 | InteliQ Tumor Marker Control MiniPak (A human based assayed tumor marker control.) |
| 03610522046065 | InteliQ Tumor Marker Control Level 3 (A human based assayed tumor marker control.) |
| 03610522046058 | InteliQ Tumor Marker Control Level 2 (A human based assayed tumor marker control.) |
| 03610522046041 | InteliQ Tumor Marker Control Level 1 (A human based assayed tumor marker control.) |
| 03610522045952 | InteliQ Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.) |
| 03610522045945 | InteliQ Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.) |
| 03610522045938 | InteliQ Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.) |
| 03610522045921 | InteliQ Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.) |
| 03610522045914 | InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.) |
| 03610522045846 | InteliQ Assayed Multiqual Control MiniPak (A human serum assayed chemistry control.) |
| 03610522045839 | InteliQ Assayed Multiqual Control Level 3 (A human serum assayed chemistry control.) |
| 03610522045822 | InteliQ Assayed Multiqual Control Level 2 (A human serum assayed chemistry control.) |
| 03610522045815 | InteliQ Assayed Multiqual Control Level 1 (A human serum assayed chemistry control.) |
| 03610520267233 | InteliQ Homocysteine Control MiniPak (A human serum assayed homocysteine control.) |
| 03610520267226 | InteliQ Homocysteine Control Level 3 (A human serum assayed homocysteine control.) |
| 03610520267219 | InteliQ Homocysteine Control Level 2 (A human serum assayed homocysteine control.) |
| 03610520242582 | InteliQ Homocysteine Control Level 1 (A human serum assayed homocysteine control.) |
| 03610522115969 | InteliQ Urine Chemistry Control Level 2 (A human urine assayed chemistry control.) |
| 03610522115952 | InteliQ Urine Chemistry Control Level 1 (A human urine assayed chemistry control.) |
| 03610522115945 | InteliQ Urine Chemistry Control Bilevel MiniPak (A human urine assayed chemistry control.) |
| 03610522114214 | InteliQ Immunoassay Plus Control MiniPak (A human serum assayed immunoassay and TDM control.) |
| 03610522114207 | InteliQ Immunoassay Plus Control Level 3 (A human serum assayed immunoassay and TDM control.) |
| 03610522114191 | InteliQ Immunoassay Plus Control Level 2 (A human serum assayed immunoassay and TDM control.) |
| 03610522114184 | InteliQ Immunoassay Plus Control Level 1 (A human serum assayed immunoassay and TDM control.) |
| 03610522046270 | InteliQ Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.) |
| 03610522046263 | InteliQ Diabetes Control Level 3 (A human whole blood assayed diabetes control.) |
| 03610522046256 | InteliQ Diabetes Control Level 2 (A human whole blood assayed diabetes control.) |
| 03610522046249 | InteliQ Diabetes Control Level 1 (A human whole blood assayed diabetes control.) |
| 03610522354665 | InteliQ Specialty Immunoassay Plus Control Level Low MiniPak (A human serum assayed immunoassay |
| 03610522231508 | InteliQ Specialty Immunoassay Plus Control Trilevel MiniPak (A human serum assayed immunoassay c |
Trademark Results [InteliQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTELIQ 87922749 not registered Live/Pending |
BIO-RAD LABORATORIES, INC. 2018-05-15 |
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