FDA.reportPublic FDA data

Proinsulin ELISA

Primary DI
00404847415605
Brand
Proinsulin ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-1560
Catalog number
EIA-1560
Device description
The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) in serum and plasma.
Published
2021-06-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKDRADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKDRadioimmunoassay, C-Peptides Of ProinsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00404847415605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847415605004048474156054048474156050404847415605

GMDN Terms#

Term, Definition table
TermDefinition
Proinsulin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of proinsulin 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)564-7555corp@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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026255AccuDiag™ C-Peptide ELISA KitDiagnostic Automation, Inc.JKD2026-01-27
04048474012934C-Peptide ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKD2024-11-22
00840239015600Proinsulin ELISADRG International IncJKD2023-08-23
15099590733377Access C-PeptideBeckman Coulter, Inc.JKD2023-07-28
06925912718642iFlash-C-PeptideShenzhen YHLO Biotech Co., Ltd.JKD2022-10-26
00404847412932C-Peptide ELISADRG Instruments Gesellschaft mit beschränkter HaftungJKD2021-06-07
04015630920129Elecsys C-PeptideRoche Diagnostics GmbHJKD2021-01-18
B24280CPTHUCH050STELLUX® Chemi Human C-peptide ELISA Lab PackAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-09-25
B24280CPTHUE100ALPCO C-peptide ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-09-25
00630414600413Atellica IM CpSSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414600437Atellica IM CpS MCMSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414464053ADVIA Centaur® CpSSiemens Healthcare Diagnostics Inc.JKD2020-09-24
00630414953007IMMULITE® Systems CPE CONTROL C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414953656IMMULITE®/IMMULITE® 1000 Systems PEP C-Peptide Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414953663IMMULITE® 2000 Systems PEP C-Peptide Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414961873IMMULITE® 2000 Systems C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
00630414964430IMMULITE®/IMMULITE® 1000 Systems PEP C-PeptideSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJKD2020-09-24
05400569000049C-PEP-EASIADiasource Immunoassays S.A. SAJKD2020-09-14
B24280CPTHUCH010STELLUX® Chemi Human C-peptide ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
B24280CPTHUE010ALPCO C-peptide ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
B24280PINHUTCH010STELLUX® Chemi Human Total Proinsulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.JKD2020-07-17
00630414293615Atellica IM CpSSiemens Healthcare Diagnostics Inc.JKD2020-05-31
07350108630085Mercodia C-peptide ELISAMercodia ABJKD2020-04-08
07350108630092Mercodia Ultrasensitive C-peptide ELISAMercodia ABJKD2020-04-08
00380740156015ARCHITECTAbbott GmbH & Co. KGJKD2020-03-03
05400569000322C-PEP II-RIA-CTDiasource Immunoassays S.A. SAJKD2020-01-15
14560189212227AIA-PACK C-Peptide Control SetTOSOH CORPORATIONJKD2019-09-02
14560189213347AIA-PACK C-Peptide II Sample Diluting SolutionTOSOH CORPORATIONJKD2019-07-24
24560189213313ST AIA-PACK C-Peptide II TOSOH CORPORATIONJKD2019-07-24
00816870020730Monobind AccuBind C-Peptide ELISA Kit - 96 WellsMONOBIND, INC.JKD2019-02-11