The calcium test system is a device intended for the quantitative in vitro determination of calcium in serum, plasma or urine

The calcium test system is a device intended for the quantitative in vitro determination of calcium in serum, plasma or urine
Ca - CA590

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of calcium (Ca2+) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Stable for 7 days at +2 to +8°C or 3 days at +15 to +25°C once reconstituted.

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: CIC

Device Name: Cresolphthalein Complexone, Calcium

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: 862.1145

Third Party Flag: Y

Medical Specialty: CH

Device Identifiers

Device Id: 05055273200911

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