FDA.reportPublic FDA data

Total Estrogens ELISA

Primary DI
B24211ESTTHUE010
Brand
Total Estrogens ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
11-ESTTHU-E01
Catalog number
11-ESTTHU-E01
Device description
The Total Estrogens ELISA is for the direct quantitative determination of total estrogens (estrone, estradiol, and estriol) in human serum by enzyme immunoassay. For in vitro diagnostic use.
Published
2020-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMDRadioimmunoassay, Total Estrogens, Nonpregnancy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMDRadioimmunoassay, Total Estrogens, NonpregnancyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B24211ESTTHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total estrogen (oestrogen) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total estrogen (oestrogen) hormones [estradiol, estriol, and estrone] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of sex steroid metabolism-related conditions (e.g., premature or delayed puberty), or assessment of fracture risk and monitoring of hormone replacement therapy in postmenopausal women.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817830023075MP Biomedicals LLCMp Biomedicals, LLCJMD2023-08-02
00817830023082MP Biomedicals LLCMp Biomedicals, LLCJMD2023-08-02
B652IB59134Total Estrogens ELISAIBL AmericaJMD2023-06-08
B261CANE6304PK0DBC Total Estrogens ELISADiagnostics Biochem Canada IncJMD2023-01-06
04049016147206Total Estrogens ELISAEUROIMMUN Medizinische Labordiagnostika AGJMD2022-12-08
B261CANE6300DBC Total Estrogens ELISADiagnostics Biochem Canada IncJMD2022-11-10
B261CANE6308PK0DBC Total Estrogens ELISADiagnostics Biochem Canada IncJMD2022-11-10
B24211ESGTHUE010Total Estrogens ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JMD2022-09-09