IgM (Immunoglobulin M) 2 x 60 tests

IgM (Immunoglobulin M) 2 x 60 tests
CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638 - CC638

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis G virus in a clinical specimen, using an enzyme immunoassay (EIA) method.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable when stored at 2-8° C until expiration date

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 8 Milliliter

Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert

Total Volume: 23 Milliliter

Total Volume: 8 Milliliter
Kit contains 2 Reagent cartridges, 1 user defined paramenter and 1 package insert
Total Volume: 23 Milliliter

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CFF

Device Name: Immunoelectrophoretic, Immunoglobulins, (G, A, M)

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: 866.5510

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 00817302020953

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