- Physicians Office Resource

The Access AFP Sample Diluent is intended for use with the Access AFP assay to dilute patient samples containing AFP concentrations greater than the S6 calibrator.
Access AFP Sample Diluent - 33216

Device Description

A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen using a chemiluminescent immunoassay method, in order to predict the risk of trisomy 21 (Down syndrome) as part of a first or second trimester screening assessment. Hormones assayed may include alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), pregnancy associated plasma protein A (PAPP-A), estriol and/or inhibin A.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LOK

Device Name: Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: H628332161

Device Type: Primary

DeviceId Issuing Agency: HIBCC

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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