BioCheck High Sensitive CRP EIA Test Kit BC-1119

GUDID 00850392007190

BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.

BIOCHECK, INC.

C-reactive protein (CRP) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00850392007190
• NIH Device Record Key: 019ba6eb-6c92-49c3-a4fd-060a7ef8cd4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCheck High Sensitive CRP EIA Test Kit
• Version Model Number: BC-1119
• Catalog Number: BC-1119
• Company DUNS: 171857493
• Company Name: BIOCHECK, 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: true
• 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: (650)573-1968
• Email: info@biocheckinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850392007190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003851

FDA Product Code

• DCK: C-Reactive Protein, Antigen, Antiserum, And Control

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: 2019-10-16
• Device Publish Date: 2019-10-08

Devices Manufactured by BIOCHECK, INC.

• 00850392007015 - BioCheck TSH EIA Test Kit: 2019-10-16 The BioCheck TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration
• 00850392007039 - BioCheck U-TSH EIA Test Kit: 2019-10-16 The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentratio
• 00850392007053 - BioCheck T3 EIA Test Kit: 2019-10-16 The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human seru
• 00850392007077 - BioCheck T4 EIA Test Kit: 2019-10-16 The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum
• 00850392007176 - BioCheck Myoglobin EIA Test Kit: 2019-10-16 The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum.
• 00850392007190 - BioCheck High Sensitive CRP EIA Test Kit: 2019-10-16BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.
• 00850392007190 - BioCheck High Sensitive CRP EIA Test Kit: 2019-10-16 BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.
• 00850392007251 - BioCheck Human Ferritin EIA Test Kit: 2019-10-16 The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin in human serum.
• 00850392007275 - BioCheck hCG EIA Test Kit: 2019-10-16 The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration