FDA.report

Metanephrine (Urine) ELISA

Primary DI
00404847427486
Brand
Metanephrine (Urine) ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-2748
Catalog number
EIA-2748
Device description
Enzyme immunoassay for the quantitative determination of metanephrine in human urine.
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

Related Records

Contact Domains

Product Codes

CodeName
CHQCHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES

Product Code Classifications

CodeDeviceSpecialtyClass
CHQChromatographic/Fluorometric Method, CatecholaminesClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00404847427486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847427486004048474274864048474274860404847427486

GMDN Terms

TermDefinition
Multiple biogenic amine neurotransmitter IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norepinephrine, epinephrine), histamine, serotonin] and/or multiple biogenic amine neurotransmitter intermediate metabolites (e.g., metanephrine, normetanephrine, 3-methoxytyramine) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

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 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
04250317557070Reagent Chromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557087Reagent Chromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557506Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557513Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557544Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557551Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557568Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557575Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557582Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557599Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
00404847419085Adrenaline ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHQ2021-06-07
00404847431759Catcombi ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHQ2021-06-07
04250317502957AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503190ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503213ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503220ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503244ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503268AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503275AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503299ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317519276ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317526359ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317526366ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503084ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503138ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503145ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503169ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503176ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317511058ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317511263ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28