FDA.reportPublic FDA data

Androstenedione

Primary DI
04048474053395
Brand
Androstenedione
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
HYE-5339
Catalog number
HYE-5339
Device description
The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum.
Published
2023-09-01
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
CIZRadioimmunoassay, Androstenedione

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIZRadioimmunoassay, AndrostenedioneClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474053395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474053395040484740533954048474053395

GMDN Terms#

Term, Definition table
TermDefinition
Androstenedione IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione 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
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000824AccuDiag™ ANST (Androstenedione) ELISADiagnostic Automation, Inc.CIZ2026-01-27
00816870023816ANST AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CIZ2024-09-13
00816870023823ANST AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CIZ2024-09-13
00816870024707ANST AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CIZ2024-09-13
00816870024714ANST AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CIZ2024-09-13
04048474032659Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2023-08-29
00840239053398AndrostenedioneDRG International IncCIZ2023-08-26
00840239032652Androstenedione ELISADRG International IncCIZ2023-08-24
05060169691261IDS AndrostenedioneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCIZ2023-06-27
04049016138365Androstenedione ELISAEUROIMMUN Medizinische Labordiagnostika AGCIZ2022-12-08
B261CANAD2080DBC Androstenedione ELISADiagnostics Biochem Canada IncCIZ2022-11-15
06925912718055iFlash-AndrostenedioneShenzhen YHLO Biotech Co., Ltd.CIZ2022-10-26
00404847432657Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
00404847450507Androstenedione ELISADRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
00404847453393AndrostenedioneDRG Instruments Gesellschaft mit beschränkter HaftungCIZ2021-06-07
05400569000346ANDROSTENEDIONE-RIA-CTDiasource Immunoassays S.A. SACIZ2020-10-05
B24211ANRHUE010Androstenedione ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CIZ2020-09-25
00630414961026IMMULITE® 2000 Systems AND AndrostenedioneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCIZ2020-09-24
00630414963570IMMULITE®/IMMULITE® 1000 Systems AND AndrostenedioneSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCIZ2020-09-24
05400569000865Androstenedione-ELISADiasource Immunoassays S.A. SACIZ2020-09-14
07613336169292Elecsys AndrostenedioneRoche Diagnostics GmbHCIZ2020-03-05
07613336169308Elecsys AndrostenedioneRoche Diagnostics GmbHCIZ2020-03-05
00630414285566Atellica IM Androstenedione kitSiemens Healthcare Diagnostics Inc.CIZ2019-12-04
00630414603445ADVIA Centaur Androstenedione kitSiemens Healthcare Diagnostics Inc.CIZ2019-10-25