The paracetamol test system is intended for the quantitative in vitro determination of Acetaminophen in human serum.

The paracetamol test system is intended for the quantitative in vitro determination of Acetaminophen in human serum.
ACE - ACE4023

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 qualitative and/or quantitative detection of acetaminophen in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Do not freeze. Stable on board analyser for 7 days at approx 10 DegC

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LDP

Device Name: Colorimetry, Acetaminophen

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

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: 862.3030

Third Party Flag: Y

Medical Specialty: TX

Device Identifiers

Device Id: 05055273208139

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