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 ID00847661001690
NIH Device Record Keyb1446b15-3a22-4184-b07d-b3b174cbd71b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLyphochek
Version Model Number528
Catalog Number528
Company DUNS051624070
Company NameBIO-RAD LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847661001690 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DIEHEAVY METALS CONTROL MATERIALS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-23
Device Publish Date2017-01-09

On-Brand Devices [Lyphochek]

00847661005698Lyphochek Hemoglobin A1C Linearity Set (Hemoglobin A1C linearity verification material.)
00847661004073Lyphochek Urine Metals Control MiniPak (A human urine assayed metals control.)
00847661002185Lyphochek Diabetes Control Bilevel MiniPak (A human whole blood assayed diabetes control.)
00847661002147Lyphochek Benzo/TCA Control- Set B MiniPak (A human serum assayed benzodiazepines and TCA contro
00847661002130Lyphochek Benzo/TCA Control- Set A MiniPak (A human serum assayed benzodiazepines and TCA contro
00847661002093Lyphochek Hemoglobin A2 Control Bilevel MiniPak (A human whole blood assayed Hemoglobin A2 cont
00847661002079Lyphochek Endocrine Control MiniPak (A human serum quantitative catecholamines control.)
00847661002055Lyphochek Drug Free Serum MiniPak (A human drug free serum control.)
00847661002024Lyphochek Urine Bone Markers Control MiniPak (A human urine bone markers control.)
00847661001959Lyphochek Coagulation Control Level Trilevel MiniPak (A human plasma coagulation control.)
00847661001898Lyphochek Hemostasis Control MiniPak (A human plasma hemostasis control.)
00847661001867Lyphochek Whole Blood Control MiniPak (A human whole blood assayed control.)
00847661001843Lyphochek Whole Blood Metals Control MiniPak (A human whole blood assayed metals control.)
00847661001706Lyphochek Whole Blood Metals Control Level 3 (A human whole blood assayed metals control.)
00847661001690Lyphochek Whole Blood Metals Control Level 2 (A human whole blood assayed metals control.)
00847661001683Lyphochek Whole Blood Metals Control Level 1 (A human whole blood assayed metals control.)
00847661001676Lyphochek Whole Blood Control Level 3 (A human whole blood assayed control.)
00847661001669Lyphochek Whole Blood Control Level 2 (A human whole blood assayed control.)
00847661001652Lyphochek Whole Blood Control Level 1 (A human whole blood assayed control.)
00847661001607Lyphochek Urine Bone Markers Control Bilevel (A human urine bone markers control.)
00847661001041Lyphochek Hemostasis Control Level 3 (A human plasma hemostasis control.)
00847661001034Lyphochek Hemostasis Control Level 2 (A human plasma hemostasis control.)
00847661001027Lyphochek Hemostasis Control Level 1 (A human plasma hemostasis control.)
00847661000976Lyphochek Endocrine Control Bilevel (A human serum quantitative catecholamines control.)
00847661000907Lyphochek Drug Free Serum (A human drug free serum control.)
00847661000884Lyphochek Hemoglobin A2 Control Bilevel (A human whole blood assayed Hemoglobin A2 control.)
00847661000860Lyphochek Diabetes Control Bilevel (A human whole blood assayed diabetes control.)
00847661000792Lyphochek Coagulation Control Level 3 (A human plasma coagulation control.)
00847661000785Lyphochek Coagulation Control Level 2 (A human plasma coagulation control.)
00847661000778Lyphochek Coagulation Control Level 1 (A human plasma coagulation control.)
00847661000600Lyphochek Benzo/TCA Control- Set B Level 2 (A human serum assayed benzodiazepines and TCA contro
00847661000594Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA contro
00847661000587Lyphochek Benzo/TCA Control- Set A Level 2 (A human serum assayed benzodiazepines and TCA contro
00847661000570Lyphochek Benzo/TCA Control- Set A Level 1 (A human serum assayed benzodiazepines and TCA contro
00847661000310Lyphochek Urine Toxicology Control (A human urine drugs of abuse control)
00847661000297Lyphochek Urine Metals Control Level 2 (A human urine assayed metals control.)
00847661000280Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.)
00847661005759Lyphochek Allergen sIgE Control Panel A MiniPak (An assayed human serum allergen sIgE control.)
00847661005742Lyphochek Allergen sIgE Control Negative MiniPak (An assayed human based allergen sIgE control.)
00847661005735Lyphochek Allergen sIgE Control Panel A (An assayed human serum allergen sIgE control.)
00847661005728Lyphochek Allergen sIgE Control Negative (An assayed human based allergen sIgE control.)
00847661005681Lyphochek Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)
00847661005674Lyphochek Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)
00847661005667Lyphochek Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)
00847661005650Lyphochek Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)
00847661005636Lyphochek Whole Blood Immunosuppressant Control MiniPak (A human whole blood assayed control.)
00847661003403Lyphochek Tumor Marker Plus Control Trilevel MiniPak (A human based assayed tumor marker control
00847661003342Lyphochek Whole Blood Immunosuppressant Control Level 5 (A human whole blood assayed control.)
00847661003335Lyphochek Whole Blood Immunosuppressant Control Level 4 (A human whole blood assayed control.)
00847661003328Lyphochek Whole Blood Immunosuppressant Control Level 3 (A human whole blood assayed control.)

Trademark Results [Lyphochek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LYPHOCHEK
LYPHOCHEK
86087683 4547272 Live/Registered
Bio-Rad Laboratories, Inc.
2013-10-09

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