FDA.reportPublic FDA data

DHEA-S

Primary DI
00840239053473
Brand
DHEA-S
Company
DRG International Inc
Model
HYE-5347
Catalog number
HYE-5347
Device description
The DRG:Hybrid-XL DHEA-S is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma.
Published
2023-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00840239053473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239053473008402390534738402390534730840239053473

GMDN Terms#

Term, Definition table
TermDefinition
Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of adrenal hyperplasia and hirsutism.

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
1 973-564-7555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
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
04015630917372Elecsys DHEA-SRoche Diagnostics GmbHJKC2021-01-18