FDA.report

17 OH Progesterone ELISA

Primary DI
00840239012920
Brand
17 OH Progesterone ELISA
Company
DRG International Inc
Model
EIA-1292
Catalog number
EIA-1292
Device description
The DRG 17-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-a-OH Progesterone (17-a-OHP) in serum or plasma (EDTA, lithium heparin or citrate plasma).
Published
2023-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JLXRadioimmunoassay, 17-Hydroxyprogesterone

Product Code Classifications

CodeDeviceSpecialtyClass
JLXRadioimmunoassay, 17-HydroxyprogesteroneClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239012920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239012920008402390129208402390129200840239012920

GMDN Terms

TermDefinition
17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassayA 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 a chemiluminescent immunoassay method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
9735647555corpoffice@drg-international.com

Regulatory Flags

DUNS number
075150847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840239023858Free Triiodothyronine (fT3) ELISAEIA-2385EIA-23852024-09-23
00840239038012Free T3 ELISAEIA-3801EIA-38012024-09-23
00840239053565T3 freeHYE-5356HYE-53562024-09-23
00840239038470Mumps IgM ELISAEIA-3847EIA-38472024-08-20
00840239056979T-3HYE-5697HYE-56972024-08-13
00840239035769Anti-SS-B ELISAEIA-3576EIA-35762023-10-09
00840239048882Vitamin C (Ascorbic Acid)ENZ-4888ENZ-48882023-09-01
00084023903579Anti-SS-B ELISA EIA-3576EIA-35762023-08-25
00840239029317Salivary Progesterone ELISA SLV-2931SLV-29312023-08-26
00840239030139Salivary Testosterone ELISASLV-3013SLV-3032023-08-26
00840239031402Salivary 17-OH Progesterone ELISASLV-3140SLV-31402023-08-26
00840239035776Anti-Sm ELISAEIA-3577EIA-35772023-08-25
00840239035783Anti-RNP/Sm ELISA EIA-3578EIA-35782023-08-25
00840239035806Anti-Scl-70 ELISAEIA-3580EIA-35802023-08-25
00840239035813Anti-Jo-1 ELISAEIA-3581EIA-35812023-08-25
00840239035837Rheumatoid Factor Screen ELISAEIA-3583EIA-35832023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISAEIA-3584EIA-35842023-08-25
00840239035851Rheumatoid Factor IgM ELISAEIA-3585EIA-35852023-08-25
00840239035868Rheumatoid Factor IgA ELISAEIA-3586EIA-35862023-08-25
00840239035875Anti-Cardiolipin IgG/IgM ELISAEIA-3587EIA-35872023-08-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
00840239031402Salivary 17-OH Progesterone ELISADRG International IncJLX2023-08-26
00840239053336Progesterone (17-a-OH Progesterone)DRG International IncJLX2023-08-26
04048474014297Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISADRG Instruments Gesellschaft mit beschränkter HaftungJLX2023-08-26
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
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
0540056900047617OHP RIA CTDiasource Immunoassays S.A. SAJLX2020-01-15
00816870021430Monobind AccuBind 17OHP ELISA Kit - 96 WellsMONOBIND, INC.JLX2019-03-11
00816870021447Monobind AccuBind 17OHP ELISA Kit - 192 WellsMONOBIND, INC.JLX2019-03-11
00816870021454Monobind AccuBind 17OHP-SI ELISA Kit - 96 WellsMONOBIND, INC.JLX2019-03-11
00816870021461Monobind AccuBind 17OHP-SI ELISA Kit - 192 WellsMONOBIND, INC.JLX2019-03-11