The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. This assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus. 96 Tests.
Pointe Scientific, Inc. - F1037-96
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of prolactin in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CFT
Device Name: Radioimmunoassay, Prolactin (Lactogen)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
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: 862.1625
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00811727013279
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