Lyphochek 370

GUDID 00847661001072

Lyphochek Immunoassay Plus Control Trilevel (A human serum assayed immunoassay and TDM Control.)

BIO-RAD LABORATORIES, INC.

Multiple clinical chemistry protein IVD, control

• Primary Device ID: 00847661001072
• NIH Device Record Key: 9b8bd96d-9496-4feb-aa47-dde1f4fdfbcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyphochek
• Version Model Number: 370
• Catalog Number: 370
• 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
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: qsd.techservice@bio-rad.com
• Phone: +1(800)854-6737
• Email: 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
• 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	00847661001072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981532

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2020-09-22
• Device Publish Date: 2020-09-14

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.)