Lyphochek 528
GUDID 00847661001690
Lyphochek Whole Blood Metals Control Level 2 (A human whole blood assayed metals control.)
BIO-RAD LABORATORIES, INC.
Multiple heavy metal IVD, control| Primary Device ID | 00847661001690 |
| NIH Device Record Key | b1446b15-3a22-4184-b07d-b3b174cbd71b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lyphochek |
| Version Model Number | 528 |
| Catalog Number | 528 |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847661001690 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K020610
FDA Product Code
| DIE | HEAVY METALS CONTROL MATERIALS |
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 | 2017-01-09 |
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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