FDA.reportPublic FDA data

Total Estrogens ELISA

Primary DI
B24211ESGTHUE010
Brand
Total Estrogens ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
11-ESGTHU-E01
Catalog number
11-ESGTHU-E01
Device description
For the quantitative determination of total estrogens by an enzyme immunoassay in human serum.
Published
2022-09-09
Public version status
New
Distribution status
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
B24211ESGTHUE010PrimaryHIBCC0

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
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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
B24211ESTTHUE010Total Estrogens ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JMD2020-09-25