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 Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control Glycated haemoglobin (HbA1c) IVD, control 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.) |
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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