FDA.reportPublic FDA data

Catcombi ELISA

Primary DI
00404847431759
Brand
Catcombi ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3175
Catalog number
EIA-3175
Device description
Manual and automated enzyme immunoassay for the in-vitro diagnostic quantitative determination of adrenalin (epinephrine) and noradrenalin (norepinephrine) in human plasma and urine.
Published
2021-06-07
Public version status
Update
Distribution status
Not 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
CHQCHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHQChromatographic/Fluorometric Method, CatecholaminesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00404847431759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847431759004048474317594048474317590404847431759

GMDN Terms#

Term, Definition table
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#

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
Premarket exempt
true
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
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00404847427486Metanephrine (Urine) 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