QuanTtest Red Pyrogallol Red Reagent 5210-12

GUDID M0515210120

QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.

QUANTIMETRIX CORPORATION

Total protein IVD, reagent

• Primary Device ID: M0515210120
• NIH Device Record Key: 4d2450c4-c462-4f2b-a579-6199c884aca3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuanTtest Red Pyrogallol Red Reagent
• Version Model Number: 5210-12
• Catalog Number: 5210-12
• Company DUNS: 010717890
• Company Name: QUANTIMETRIX CORPORATION
• 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: false
• 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: (310) 536-0006
• Email: sales@quantimetrix.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00896863002349 [Primary]
HIBCC	M0515210120 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904603

FDA Product Code

• CEK: Biuret (Colorimetric), Total Protein

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: 2019-10-07
• Device Publish Date: 2019-09-27

Devices Manufactured by QUANTIMETRIX CORPORATION

• 00896863002424 - Chromascopics Control Level 1&2 Set 2x25mL (International): 2023-05-12 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus
• 00896863002356 - QuanTtest Human Protein Standards Set: 2021-09-20 QuanTtest Human Protein Standards are intended to be used with the QuanTtest Red (Pyrogallol Red method) Total Protein Assay Sys
• 00896863002004 - Dropper Spinal Fluid Control Level 1 Set 3x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002011 - Dropper Spinal Fluid Control Level 2 Set 3x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002073 - Dropper Spinal Fluid Control Level 1&2 Set 2x3mL: 2020-12-21 The Dropper Spinal Fluid Control is intended as a means of monitoring spinal fluid analyte methods to validate quantitation of p
• 00896863002042 - Chromascopics Control Level 1&2 Set 4x120mL (Domestic): 2020-01-10 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus
• M0515210120 - QuanTtest Red Pyrogallol Red Reagent: 2019-10-07QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in assays for quantitative determination of protein in cerebrospinal fluid and urine, for both manual and automated systems.
• M0515210120 - QuanTtest Red Pyrogallol Red Reagent: 2019-10-07 QuanTtest red Reagent is a ready-to-use liquid in 250 mL bottles containing Pyrogallol Red. The reagent is intended for use in a
• 00089686302042 - Chromascopics Control Level 1&2 Set 4x120mL (Domes: 2018-10-29 The Chromascopics Urinalysis Control with Microscopics is intended as an assayed quality control for the Siemens Clinitek Novus