The DRG Salivary Estradiol HS ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free estradiol in saliva.
Results may be used to assess fertility problems in women; to diagnose menopause, and to monitor hormone replacement therapy.
Salivary Estradiol HS ELISA - SLV-6145
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) 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: CHP
Device Name: Radioimmunoassay, Estradiol
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: 862.1260
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00840239061454
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