The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting.
Human Chorionic Gonadotropin (hCG) ELISA - EIA-1783
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human chorionic gonadotropin beta-core fragment, a metabolite of human chorionic gonadotropin beta-subunit (beta-HCG), in a clinical specimen, using an enzyme immunoassay (EIA) method.
Environmental Conditions
No Data Available
Device Sizes
- Total Volume: 13 Milliliter
- Total Volume: 18 Milliliter
- Conjugate Reagent
- Stop Solution
- Total Volume: 11 Milliliter
- Zero Buffer
- Standards
- Total Volume: 1 Milliliter
- TMB
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JHI
Device Name: Visual, Pregnancy Hcg, Prescription Use
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 862.1155
Third Party Flag: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 00840239017833
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