Lyphochek 553
GUDID 00847661000884
Lyphochek Hemoglobin A2 Control Bilevel (A human whole blood assayed Hemoglobin A2 control.)
BIO-RAD LABORATORIES, INC.
Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control Haemoglobin A2 (HbA2) IVD, control| Primary Device ID | 00847661000884 |
| NIH Device Record Key | 381c49e1-f163-4d6f-b4d1-341cb04d97fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lyphochek |
| Version Model Number | 553 |
| Catalog Number | 553 |
| Company DUNS | 051624070 |
| Company Name | BIO-RAD LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847661000884 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K911347
FDA Product Code
| JCM | CONTROL, HEMOGLOBIN, ABNORMAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [Lyphochek]
| 00847661005698 | Lyphochek Hemoglobin A1C Linearity Set (Hemoglobin A1C linearity verification material.) |
| 00847661004073 | Lyphochek Urine Metals Control MiniPak (A human urine assayed metals control.) |
| 00847661002185 | Lyphochek Diabetes Control Bilevel MiniPak (A human whole blood assayed diabetes control.) |
| 00847661002147 | Lyphochek Benzo/TCA Control- Set B MiniPak (A human serum assayed benzodiazepines and TCA contro |
| 00847661002130 | Lyphochek Benzo/TCA Control- Set A MiniPak (A human serum assayed benzodiazepines and TCA contro |
| 00847661002093 | Lyphochek Hemoglobin A2 Control Bilevel MiniPak (A human whole blood assayed Hemoglobin A2 cont |
| 00847661002079 | Lyphochek Endocrine Control MiniPak (A human serum quantitative catecholamines control.) |
| 00847661002055 | Lyphochek Drug Free Serum MiniPak (A human drug free serum control.) |
| 00847661002024 | Lyphochek Urine Bone Markers Control MiniPak (A human urine bone markers control.) |
| 00847661001959 | Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.) |
| 00847661001898 | Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.) |
| 00847661001867 | Lyphochek Whole Blood Control MiniPak (A human whole blood assayed control.) |
| 00847661001843 | Lyphochek Whole Blood Metals Control MiniPak (A human whole blood assayed metals control.) |
| 00847661001706 | Lyphochek Whole Blood Metals Control Level 3 (A human whole blood assayed metals control.) |
| 00847661001690 | Lyphochek Whole Blood Metals Control Level 2 (A human whole blood assayed metals control.) |
| 00847661001683 | Lyphochek Whole Blood Metals Control Level 1 (A human whole blood assayed metals control.) |
| 00847661001676 | Lyphochek Whole Blood Control Level 3 (A human whole blood assayed control.) |
| 00847661001669 | Lyphochek Whole Blood Control Level 2 (A human whole blood assayed control.) |
| 00847661001652 | Lyphochek Whole Blood Control Level 1 (A human whole blood assayed control.) |
| 00847661001607 | Lyphochek Urine Bone Markers Control Bilevel (A human urine bone markers control.) |
| 00847661001041 | Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.) |
| 00847661001034 | Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.) |
| 00847661001027 | Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.) |
| 00847661000976 | Lyphochek Endocrine Control Bilevel (A human serum quantitative catecholamines control.) |
| 00847661000907 | Lyphochek Drug Free Serum (A human drug free serum control.) |
| 00847661000884 | Lyphochek Hemoglobin A2 Control Bilevel (A human whole blood assayed Hemoglobin A2 control.) |
| 00847661000860 | Lyphochek Diabetes Control Bilevel (A human whole blood assayed diabetes control.) |
| 00847661000792 | Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.) |
| 00847661000785 | Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.) |
| 00847661000778 | Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.) |
| 00847661000600 | Lyphochek Benzo/TCA Control- Set B Level 2 (A human serum assayed benzodiazepines and TCA contro |
| 00847661000594 | Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA contro |
| 00847661000587 | Lyphochek Benzo/TCA Control- Set A Level 2 (A human serum assayed benzodiazepines and TCA contro |
| 00847661000570 | Lyphochek Benzo/TCA Control- Set A Level 1 (A human serum assayed benzodiazepines and TCA contro |
| 00847661000310 | Lyphochek Urine Toxicology Control (A human urine drugs of abuse control) |
| 00847661000297 | Lyphochek Urine Metals Control Level 2 (A human urine assayed metals control.) |
| 00847661000280 | Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.) |
| 00847661005759 | Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.) |
| 00847661005742 | Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.) |
| 00847661005735 | Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.) |
| 00847661005728 | Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.) |
| 00847661005681 | Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.) |
| 00847661005674 | Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.) |
| 00847661005667 | Lyphochek Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.) |
| 00847661005650 | Lyphochek Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.) |
| 00847661005636 | Lyphochek Whole Blood Immunosuppressant Control MiniPak (A human whole blood assayed control.) |
| 00847661003403 | Lyphochek Tumor Marker Plus Control Trilevel MiniPak (A human based assayed tumor marker control |
| 00847661003342 | Lyphochek Whole Blood Immunosuppressant Control Level 5 (A human whole blood assayed control.) |
| 00847661003335 | Lyphochek Whole Blood Immunosuppressant Control Level 4 (A human whole blood assayed control.) |
| 00847661003328 | Lyphochek Whole Blood Immunosuppressant Control Level 3 (A human whole blood assayed control.) |
Trademark Results [Lyphochek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LYPHOCHEK 86087683 4547272 Live/Registered |
Bio-Rad Laboratories, Inc. 2013-10-09 |
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