FDA.report

Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA

Primary DI
04048474014297
Brand
Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-1429
Catalog number
EIA-1429
Device description
The quantitative determination of 17-hydroxyprogesterone concentration in human whole blood by a microplate enzyme immunoassay, colorimetric.
Published
2023-08-26
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
04048474014297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048474014297040484740142974048474014297

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

Regulatory Flags

DUNS number
317134468
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
04048474040876GAD65 Ab ELISAEIA-4087EIA-40872024-12-02
04048474012880FSH ELISAEIA-1288EIA-12882024-11-22
04048474012897LH-Serum ELISAEIA-1289EIA-12892024-11-22
04048474012903LH-Urine ELISAEIA-1290EIA-12902024-11-22
04048474012910Prolactin ELISAEIA-1291EIA-12912024-11-22
04048474012934C-Peptide ELISAEIA-1293EIA-12932024-11-22
04048474015591Testosterone ELISAEIA-1559EIA-15592024-11-22
04048474015614Progesterone ELISAEIA-1561EIA-15612024-11-22
04048474015621DHEA-S ELISAEIA-1562EIA-15622024-11-22
04048474016123Free Estriol ELISAEIA-1612EIA-16122024-11-22
04048474018264Sperm Antibody ELISAEIA-1826EIA-18262024-11-22
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474023961TGF-Beta 2 ELISAEIA-2396EIA-23962024-11-22
04048474027754RF IgM (Rheumatoid Factor) ELISAEIA-2775EIA-27752024-11-22
04048474046632Progesterone (serum) ELISACLA-4663CLA-46632024-11-21
04048474046649Estradiol (serum) ELISACLA-4664CLA-46642024-11-21
0404847401292717 OH-Progesterone ELISAEIA-1292EIA-12922024-11-18
04048474023855Free Triiodothyronine (fT3) ELISAEIA-2385EIA-23852024-09-23
04048474038019Free T3 ELISAEIA-3801EIA-38012024-09-23
04048474053562T3 freeHYE-5356HYE-53562024-09-23

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
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
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