Total Estrogens ELISA

GUDID B652IB59134

Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	B652IB59134
NIH Device Record Key	be20ba54-45b2-4460-ab90-f495a81d0076
Commercial Distribution Status	In Commercial Distribution
Brand Name	Total Estrogens ELISA
Version Model Number	IB59134
Company DUNS	159853449
Company Name	IBL America
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B652IB59134 [Primary]

JMD	Radioimmunoassay, Total Estrogens, Nonpregnancy

Steralize Prior To Use	false
Device Is Sterile	false

B652IB59105 - Estrone ELISA	2023-06-16 For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).
B652IB59107 - Pregnenolone ELISA	2023-06-16 For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay).
B652IB59109 - Testosterone (Free) ELISA	2023-06-16 Enzyme immunoassay (ELISA) for the direct quantitative determination of Free Testosterone in human serum.
B652IB59110 - Prolactin ELISA	2023-06-16 For the quantitative determination of Prolactin in human serum by an enzyme immunoassay.
B652IB59134 - Total Estrogens ELISA	2023-06-16Enzyme immunoassay (ELISA) for the quantitative determination of Total Estrogens in human serum.
B652IB59134 - Total Estrogens ELISA	2023-06-16 Enzyme immunoassay (ELISA) for the quantitative determination of Total Estrogens in human serum.
B652IB793050 - Salivary Cortisol ELISA	2018-11-26 Enzyme Immunoassay for the quantitative determination of cortisol in saliva.