Prealbumin

Prealbumin
ARCHITECT - 1E02-21

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of prealbumin (transthyretin) in a clinical specimen, using a nephelometry/turbidimetry method.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

29.00
N/A

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: JZJ

Device Name: Prealbumin, Antigen, Antiserum, Control

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: IM

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: 866.5060

Third Party Flag: N

Medical Specialty: IM

Device Identifiers

Device Id: 00380740000219

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