CREA (Creatinine) 3 x 300 tests

CREA (Creatinine) 3 x 300 tests
CAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 - AU-243

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine in a clinical specimen, using a spectrophotometry method.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable when stored at 10-30° C until expiration date

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days when stored at room temperature (18 - 25° C)

Storage Environment Temperature - Degrees Celsius

30.00
8.00

Device Sizes

Total Volume: 45 Milliliter

Total Volume: 11 Milliliter

Kit contains 3 R1 and 3 R2 bottles and 1 package insert

Total Volume: 45 Milliliter
Total Volume: 11 Milliliter
Kit contains 3 R1 and 3 R2 bottles and 1 package insert

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CGX

Device Name: Alkaline Picrate, Colorimetry, Creatinine

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1225

Third Party Flag: Y

Medical Specialty: CH

Device Identifiers

Device Id: 00817302020540

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