FDA.reportPublic FDA data

Salimetrics

Primary DI
00859410006252
Brand
Salimetrics
Company
SALIMETRICS, LLC
Model
N/A
Catalog number
1-3512
Device description
Expanded Sensitivity Salivary 17Beta-Estradiol Enzyme Immunoassay Kit
Published
2023-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00859410006252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859410006252008594100062528594100062520859410006252

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

Regulatory Flags#

DUNS number
084843064
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
00859410006351SalimetricsN/A5016.042025-12-10
00859410006368SalimetricsN/A5016.04B2025-12-10
00859410006375SalimetricsN/A5001.022025-12-10
00859410006344SalivaBioN/A5001.06B2025-11-24
00859410006283SalimetricsN/A5004.012024-12-27
00859410006290SalimetricsN/A5004.042024-12-27
00859410006306SalimetricsN/A5004.022024-12-27
00859410006313SalimetricsN/A5004.032024-12-27
00859410006320SalimetricsN/A5004.062024-12-27
00859410006337SalimetricsN/A5004.052024-12-27
00859410006269SalimetricsN/A1-44102024-09-18
00859410006276SalimetricsN/A1-4410-52024-09-18
00859410006245SalimetricsN/A1-3512-52023-09-26
00859410006139SalimetricsN/A1-23122022-08-23
00859410006177SalimetricsN/A1-2312-52022-08-23
00859410006009SalivaBioN/A5016.042022-10-13
00859410006214SalivaBioN/A5016.04B2022-10-13
00859410006221SalivaBioN/A5016.062022-10-13
00859410006238SalivaBioN/A5016.06B2022-10-13
00859410006184SalivaBioN/A5001.082022-10-13

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
14560189216621CL AIA-PACK hs-E2 TEST CUPTOSOH CORPORATIONCHP2025-09-01
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
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
00840239026934Estradiol ELISADRG International IncCHP2023-08-23
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