FDA.reportPublic FDA data

Salivary 17-OH Progesterone ELISA

Primary DI
00840239031402
Brand
Salivary 17-OH Progesterone ELISA
Company
DRG International Inc
Model
SLV-3140
Catalog number
SLV-3140
Device description
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-a-hydroxyprogesterone 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
JLXRadioimmunoassay, 17-Hydroxyprogesterone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLXRadioimmunoassay, 17-HydroxyprogesteroneClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062534000ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONEDrg Intl., Inc.2008-01-29JLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239031402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239031402008402390314028402390314020840239031402

GMDN Terms#

Term, Definition table
TermDefinition
17-Hydroxyprogesterone 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 17-hydroxyprogesterone in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of congenital adrenal hyperplasia (CAH).

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
B261CANP5400DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2026-04-27
00894175000770AccuDiag™ 17-alpha-OH Progesterone ELISADiagnostic Automation, Inc.JLX2026-01-27
0404847401292717 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2024-11-18
00816870021164N-17-OHP AccuBind ELISA Test System - 96 WellsMONOBIND, INC.JLX2024-09-13
00816870021171N-17-OHP AccuBind ELISA Test System - 192 WellsMONOBIND, INC.JLX2024-09-13
00816870021188N-17-OHP AccuBind ELISA Test System - 480 WellsMONOBIND, INC.JLX2024-09-13
00816870021195N-17-OHP AccuBind ELISA Test System - 960 WellsMONOBIND, INC.JLX2024-09-13
00816870021201N-17-OHP AccuBind ELISA Test System - 1920 WellsMONOBIND, INC.JLX2024-09-13
04048474031409Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
04048474053333Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-09-01
00840239053336Progesterone (17-a-OH Progesterone)DRG International IncJLX2023-08-26
04048474014297Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-08-26
0084023901292017 OH Progesterone ELISADRG International IncJLX2023-08-23
00840239012937C-Peptide ELISADRG International IncJLX2023-08-23
00840239014290Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG International IncJLX2023-08-23
00840239046659Progesterone, 17-a-OHDRG International IncJLX2023-08-22
00817830023150MP Biomedicals LLCMp Biomedicals, LLCJLX2023-08-02
0404932503362717-OH-Progesterone ELISAIBL International GmbHJLX2022-12-28
0404901613838917-OH Progesterone ELISAEUROIMMUN Medizinische Labordiagnostika AGJLX2022-12-08
B261CANP3200DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
B261CANP4000DBC 17α-Hydroxyprogesterone (17α-OHP) ELISADiagnostics Biochem Canada IncJLX2022-11-15
06925912718048iFlash-17α-OH-PShenzhen YHLO Biotech Co., Ltd.JLX2022-10-26
0040484741292517 OH-Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847431407Salivary 17-OH Progesterone ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847446654Progesterone, 17-a-OH ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00404847453331Progesterone (17-a-OH Progesterone)DRG Instruments Gesellschaft mit beschränkter HaftungJLX2021-06-07
00725609000625SPOTCHECKASTORIA-PACIFIC, INC.JLX2020-12-17
B2422017OHUE01017-alpha Hydroxy Progesterone ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
B2422017OHUE01SLV017-alpha Hydroxy Progesterone ELISA (Saliva)AMERICAN LABORATORY PRODUCTS COMPANY, LTD.JLX2020-06-18
0540056900047617OHP RIA CTDiasource Immunoassays S.A. SAJLX2020-01-15