FDA.report

Adrenaline ELISA

Primary DI
00404847419085
Brand
Adrenaline ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-1908
Catalog number
EIA-1908
Device description
Manual and automated enzyme immunoassay for the in vitro diagnostic quantitative determination of adrenalin (epinephrine) in human plasma and 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
00404847419085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847419085004048474190854048474190850404847419085

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

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