The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.

The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha
Access AFP - 33211

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

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Implant Flag: N

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Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: H628332111

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

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