The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine

The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine
CREA - CR8316

Device Description

A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Once opened and capped stable for 21 days when stored at 2-8°C

Storage Environment Temperature - Degrees Celsius

25.00
15.00

Device Sizes

No Data Available

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: 05055273208634

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