Autoimmune EIA Anti-Sm/RNP Test

Autoimmune EIA Anti
Autoimmune EIA - 96SR

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

96 Tests

96 Tests

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LKO

Device Name: Anti-Rnp Antibody, Antigen And Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 866.5100

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00847817022456

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