FDA.reportPublic FDA data

Estrone ELISA

Primary DI
04049016148388
Brand
Estrone ELISA
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
EQ 6165-9601-1
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
CGFRadioimmunoassay, Estrone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGFRadioimmunoassay, EstroneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049016148388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016148388040490161483884049016148388

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
04049016152033WASH REAGENT 1ZM 0121-0050-R2026-10-30
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099055IFA 40: HEp-20-10FA 1522-1050-12016-09-24
04049016145646EURORealTime SARS-CoV-2MP 2606-01252020-08-04
04049016145653EURORealTime SARS-CoV-2MP 2606-02252020-08-04
04049016145660EURORealTime SARS-CoV-2MP 2606-04252020-08-04
04049016145691EURORealTime SARS-CoV-2MP 2606-01002020-08-04
04049016145745EURORealTime SARS-CoV-2MP 2606-02002020-08-04
04049016151272FITC-labelled anti-human IgG (primate absorbed)AF 302-0540-R2026-06-10
04049016151289Biotin-labelled anti-human IgGAF 402-0540-1-R2026-06-10
04049016151296FITC-labelled Avidin (biotin affine)AF 402-0540-2-R2026-06-10
04049016151630FITC-labelled anti-human IgG (primate absorbed)AF 302-0546-R2026-06-10
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474040791Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474041743Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-31
04048474046540Estrone SerumDRG Instruments Gesellschaft mit beschränkter HaftungCGF2023-08-26
00840239041746Estrone ELISADRG International IncCGF2023-08-25
15099590211547Estrone-sulfate RIAIMMUNOTECH s.r.o.CGF2023-07-06
15099590211615Estrone RIAIMMUNOTECH s.r.o.CGF2023-07-06
B652IB59105Estrone ELISAIBL AmericaCGF2023-06-08
B261CANE4200DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
B261CANE4208PK0DBC Estrone ELISADiagnostics Biochem Canada IncCGF2022-11-10
00404847441741Estrone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCGF2021-06-07
00840239040794Estrone ELISADRG International IncCGF2021-06-07
00840239046543Estrone Serum ELISADRG International IncCGF2021-06-07
B24211ESRHUE010Estrone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CGF2020-09-25
05400569000674Estrone-RIA-CTDiasource Immunoassays S.A. SACGF2020-09-16
05400569005167Estrone ELISADiasource Immunoassays S.A. SACGF2020-01-09