FDA.reportPublic FDA data

Estradiol ELISA

Primary DI
00840239026934
Brand
Estradiol ELISA
Company
DRG International Inc
Model
EIA-2693
Catalog number
EIA-2693
Device description
The DRG Estradiol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of estradiol in serum or plasma (EDTA, lithium heparin or citrate plasma).
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHPRadioimmunoassay, Estradiol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHPRadioimmunoassay, EstradiolClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239026934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239026934008402390269348402390269340840239026934

GMDN Terms#

Term, Definition table
TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.

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
9735647555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239023858Free Triiodothyronine (fT3) ELISAEIA-2385EIA-23852024-09-23
00840239038012Free T3 ELISAEIA-3801EIA-38012024-09-23
00840239053565T3 freeHYE-5356HYE-53562024-09-23
00840239038470Mumps IgM ELISAEIA-3847EIA-38472024-08-20
00840239056979T-3HYE-5697HYE-56972024-08-13
00840239035769Anti-SS-B ELISAEIA-3576EIA-35762023-10-09
00840239048882Vitamin C (Ascorbic Acid)ENZ-4888ENZ-48882023-09-01
00084023903579Anti-SS-B ELISA EIA-3576EIA-35762023-08-25
00840239029317Salivary Progesterone ELISA SLV-2931SLV-29312023-08-26
00840239030139Salivary Testosterone ELISASLV-3013SLV-3032023-08-26
00840239031402Salivary 17-OH Progesterone ELISASLV-3140SLV-31402023-08-26
00840239035776Anti-Sm ELISAEIA-3577EIA-35772023-08-25
00840239035783Anti-RNP/Sm ELISA EIA-3578EIA-35782023-08-25
00840239035806Anti-Scl-70 ELISAEIA-3580EIA-35802023-08-25
00840239035813Anti-Jo-1 ELISAEIA-3581EIA-35812023-08-25
00840239035837Rheumatoid Factor Screen ELISAEIA-3583EIA-35832023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISAEIA-3584EIA-35842023-08-25
00840239035851Rheumatoid Factor IgM ELISAEIA-3585EIA-35852023-08-25
00840239035868Rheumatoid Factor IgA ELISAEIA-3586EIA-35862023-08-25
00840239035875Anti-Cardiolipin IgG/IgM ELISAEIA-3587EIA-35872023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026682AccuDiag™ Estradiol ELISA Diagnostic Automation, Inc.CHP2026-01-27
07613336232125Ionify Steroids 1Roche Diagnostics GmbHCHP2025-12-11
24560189216628CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
04048474046649Estradiol (serum) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2024-11-21
0404932503053417beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
0404932503054117beta-Estradiol Saliva Luminescence ImmunoassayIBL International GmbHCHP2023-09-29
00859410006245SalimetricsSALIMETRICS, LLCCHP2023-09-26
00859410006252SalimetricsSALIMETRICS, LLCCHP2023-09-26
04048474041880Salivary Estradiol ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474053494EstradiolDRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474061451Salivary Estradiol HS ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-09-01
04048474043990Estradiol Sensitive ELISA DRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-31
04048474026931Estradiol ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHP2023-08-29
00840239041883Salivary Estradiol ELISA DRG International IncCHP2023-08-26
00840239053497EstradiolDRG International IncCHP2023-08-26
00840239061454Salivary Estradiol HS ELISADRG International IncCHP2023-08-26
00840239043993Estradiol Sensitive ELISADRG International IncCHP2023-08-25
00840239046642Estradiol (serum)DRG International IncCHP2023-08-22
00817830023037MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023044MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023051MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
00817830023068MP Biomedicals LLCMp Biomedicals, LLCCHP2023-08-01
15099590211523Ultra-sensitive Estradiol RIAIMMUNOTECH s.r.o.CHP2023-07-06
15099590699383Access Sensitive EstradiolBeckman Coulter, Inc.CHP2023-06-26
00894175000787AccuDiag ™Diagnostic Automation, Inc.CHP2023-06-14
B24220EDLHUUE010Ultrasensitive Estradiol ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CHP2023-06-07
00850039602740PantexPantexCHP2023-03-17
0404932503055817beta-Estradiol Saliva ELISAIBL International GmbHCHP2023-03-09
00850039602467PantexPantexCHP2023-02-17
B261CANE4300DBC Estradiol ELISADiagnostics Biochem Canada IncCHP2022-11-15