SPECIFIC GRAVITY REAGENT

SPECIFIC GRAVITY REAGENT
CAROLINA LIQUID CHEMISTRIES CORP.® SPECIFIC GRAVITY REAGENT REAGENT KIT CC446 - CC446

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine to determine specific gravity within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

• Kit contains 2 R1 bottles
• Total Volume: 500 Milliliter

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PPM

Device Name: General Purpose Reagent

Device Class: 1

Physical State: N/A

Definition: A general purpose reagent is a chemical reagent that has general laboratory application, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application. It may be either an individual substance, or multiple substances reformulated, which, when combined with or used in conjunction with an appropriate analyte specific reagent (ASR) and other general purpose reagents, is part of a diagnostic test procedure or system constituting a finished in vitro diagnostic (IVD) test.

Submission Type ID: 4

Review Panel: PA

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Diagnostic

Regulation Number: 864.4010

Third Party Flag: N

Medical Specialty: PA

Device Id: 00817302024302

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A