FDA.reportPublic FDA data

Total Estrogens ELISA

Primary DI
04049016147206
Brand
Total Estrogens ELISA
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EQ 6160-9601-1
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04049016147206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016147206040490161472064049016147206

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

Regulatory Flags#

DUNS number
322209263
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24
04049016099031IFA 40: HEp-20-10FA 1522-2010-12016-09-24

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