- Physicians Office Resource

CYFRA 21-1 EIA - 211-10

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple cytokeratin subtype(s) in a clinical specimen, using a chemiluminescent immunoassay method.

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

25.00
20.00

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests

Size Type = Tests per kit; Size Unit = 96; Unit of Measure = Tests

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OVK

Device Name: Cytokeratin Fragments 21-1 Eia Kit

Device Class: 2

Physical State: plastic microtiter plate, plate reader system

Definition: The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

Submission Type ID: 1

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Enzyme immunoassay to quantify soluble cytokeratin 19 in human serum.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Patient serum

Regulation Number: 866.6010

Third Party Flag: Y

Medical Specialty: IM

Device Identifiers

Device Id: 17350066140135

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

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