FDA.reportPublic FDA data

Salivary Testosterone ELISA

Primary DI
00840239030139
Brand
Salivary Testosterone ELISA
Company
DRG International Inc
Model
SLV-3013
Catalog number
SLV-303
Device description
The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.
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
CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDZRadioimmunoassay, Testosterones And DihydrotestosteroneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052649000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052649000DRG SLV TESTOSTERONE ELISA TESTDrg Intl., Inc.2006-01-27CDZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239030139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239030139008402390301398402390301390840239030139

GMDN Terms#

Term, Definition table
TermDefinition
Total testosterone 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 total testosterone 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
1 973-564-7555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
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
07613336217832Elecsys Testosterone IIRoche Diagnostics GmbHCDZ2026-04-21
05060169690721IDS-iSYS Total TestosteroneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCDZ2026-04-17
05060169691230IDS-iSYS Free TestosteroneIMMUNODIAGNOSTIC SYSTEMS LIMITEDCDZ2025-11-03
04048474015591Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2024-11-22
00894175000763AccuDiag ™Diagnostic Automation, Inc.CDZ2024-01-30
04048474030136Salivary Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474061017Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-09-01
04048474046380Free Testosterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDZ2023-08-31
00840239015594Testosterone ELISADRG International IncCDZ2023-08-23
00817830023211MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-03
00817830023204MP Biomedicals LLCMp Biomedicals, LLCCDZ2023-08-02
15099590211530ACTIVE Free Testosterone RIAIMMUNOTECH s.r.o.CDZ2023-07-06
00894175000817AccuDiag ™Diagnostic Automation, Inc.CDZ2023-07-05
B652IB59109Testosterone (Free) ELISAIBL AmericaCDZ2023-06-08
00850039602726PantexPantexCDZ2023-03-17
00850039602290PantexPantexCDZ2023-02-17
00850039602672PantexPantexCDZ2023-02-17
04987270235393Lumipulse G Testosterone Immunoreaction CartridgesFUJIREBIO INC.CDZ2023-02-01
04049016137740Free Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
04049016140085Total Testosterone ELISAEUROIMMUN Medizinische Labordiagnostika AGCDZ2022-12-08
B261CANTE2500DBC Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-15
B261CANFTE2600DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
B261CANFTE260LC80DBC Free Testosterone ELISADiagnostics Biochem Canada IncCDZ2022-11-10
00850039602207Pantex P635STPantexCDZ2022-05-23
00850039602214Pantex P635STPantexCDZ2022-05-23
00850039602221Pantex P635STPantexCDZ2022-05-23
00850039602238Pantex P635STPantexCDZ2022-05-23
00850039602245Pantex P635STPantexCDZ2022-05-23
00850039602252Pantex P635STPantexCDZ2022-05-23
00850039602269Pantex UniversalPantexCDZ2022-05-23