FDA.reportPublic FDA data

Elecsys DHEA-S

Primary DI
04015630940387
Brand
Elecsys DHEA-S
Company
Roche Diagnostics GmbH
Model
07027192190
Catalog number
07027192190
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630940387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630940387040156309403874015630940387

GMDN Terms#

Term, Definition table
TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius8 Degrees Celsius

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336232132Ionify Steroids 2Roche Diagnostics GmbHJKC2025-12-11
04049325034754DHEA ELISAIBL International GmbHJKC2025-04-30
00630414652597Atellica IM DHEAS2 (REF) 500TSiemens Healthcare Diagnostics Inc.JKC2025-03-20
00630414632926Atellica IM DHEAS2 100T KITSiemens Healthcare Diagnostics Inc.JKC2025-03-20
00630414321486Atellica IM DHEAS2 (REF) 500TSiemens Healthcare Diagnostics Inc.JKC2025-03-20
04048474015621DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2024-11-22
04048474053463DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474053470DHEA-S DRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-09-01
04048474034158DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-29
00840239053466DHEADRG International IncJKC2023-08-26
00840239053473DHEA-S DRG International IncJKC2023-08-26
04048474046526DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2023-08-26
00840239034151DHEA ELISADRG International IncJKC2023-08-24
00840239015624DHEA-S ELISADRG International IncJKC2023-08-23
00817830023020MP Biomedicals LLCMp Biomedicals, LLCJKC2023-08-01
15099590211509DHEA-S-7 RIAIMMUNOTECH s.r.o.JKC2023-07-06
04049016152170Dehydroepiandrosterone (DHEA) ELISAEUROIMMUN Medizinische Labordiagnostika AGJKC2022-12-08
04049016140368Dehydroepiandrosterone Sulfate (DHEA-S) ELISAEUROIMMUN Medizinische Labordiagnostika AGJKC2022-12-08
B261CANDH4900DBC Dehydroepiandrosterone (DHEA) ELISADiagnostics Biochem Canada IncJKC2022-11-10
B261CANDHS4800DBC Dehydroepiandrosterone Sulfate (DHEAS) ELISADiagnostics Biochem Canada IncJKC2022-11-10
06925912718550iFlash-DHEA-SShenzhen YHLO Biotech Co., Ltd.JKC2022-10-26
B24211HEAHUE010Dehydroepiandrosterone (DHEA) ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
B24220DHSHUE010DHEA-S ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKC2022-09-09
15099590201432Access DHEA-SBeckman Coulter, Inc.JKC2021-09-23
15099590201449Access DHEA-S CalibratorsBeckman Coulter, Inc.JKC2021-09-23
00404847415629DHEA-S ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847434156DHEA ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453461DHEADRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00404847453478DHEA-SDRG Instruments Gesellschaft mit beschränkter HaftungJKC2021-06-07
00840239046529DHEA-S ELISADRG International IncJKC2021-06-07