FDA.reportPublic FDA data

IDS High Sensitive Estradiol

Primary DI
05060169693630
Brand
IDS High Sensitive Estradiol
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
IS-5200HS
Catalog number
IS-5200HS
Device description
For In Vitro Diagnostic Use. For Laboratory Professional Use. IDS High Sensitive Estradiol assay is an automated in vitro diagnostic device intended for the quantitative determination of estradiol in human serum on the IDS system. Results are to be used in conjunction with other clinical and laboratory data as an aid in the diagnosis and monitoring of estrogen disorders in the adult men and postmenopausal women, and paediatric population.
Published
2026-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

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
05060169693630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169693630050601696936305060169693630

GMDN Terms#

Term, Definition table
TermDefinition
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+4401915190660ids-ts.global@revvity.com

Regulatory Flags#

DUNS number
494268600
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
false
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
05060169690745IDS EstradiolIS-5200IS-52002026-06-25
05060169690899IDS High Sensitive Estradiol Control SetIS-5230HSIS-5230HS2026-06-24
05060169691087IDS Estradiol Calibrator SetIS- 5220IS-52202026-06-24
05060169697218IDS High Sensitive Estradiol Calibrator SetIS-5220HSIS-5220HS2026-06-24
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691261IDS AndrostenedioneIS-54002023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060169690745IDS EstradiolIMMUNODIAGNOSTIC SYSTEMS LIMITEDCHP2026-06-25
07613336218389Elecsys Estradiol IIIRoche Diagnostics GmbHCHP2026-06-01
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
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
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