FDA.report

Serotonin ELISA

Primary DI
00840239013002
Brand
Serotonin ELISA
Company
DRG International Inc
Model
EIA-1300
Catalog number
EIA-1300
Device description
Enzyme immunoassay for the in-vitro diagnostic quantitative determination of Serotonin in human serum, plasma, platelets and urine.
Published
2023-08-23
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
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

Product Code Classifications

CodeDeviceSpecialtyClass
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/SerotoninClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239013002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239013002008402390130028402390130020840239013002

GMDN Terms

TermDefinition
Serotonin IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of serotonin in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
9735647555corpoffice@drg-international.com

Regulatory Flags

DUNS number
075150847
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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00084023903579Anti-SS-B ELISA EIA-3576EIA-35762023-08-25
00840239029317Salivary Progesterone ELISA SLV-2931SLV-29312023-08-26
00840239030139Salivary Testosterone ELISASLV-3013SLV-3032023-08-26
00840239031402Salivary 17-OH Progesterone ELISASLV-3140SLV-31402023-08-26
00840239035776Anti-Sm ELISAEIA-3577EIA-35772023-08-25
00840239035783Anti-RNP/Sm ELISA EIA-3578EIA-35782023-08-25
00840239035806Anti-Scl-70 ELISAEIA-3580EIA-35802023-08-25
00840239035813Anti-Jo-1 ELISAEIA-3581EIA-35812023-08-25
00840239035837Rheumatoid Factor Screen ELISAEIA-3583EIA-35832023-08-25
00840239035844RF IgG (Rheumatoid Factor) ELISAEIA-3584EIA-35842023-08-25
00840239035851Rheumatoid Factor IgM ELISAEIA-3585EIA-35852023-08-25
00840239035868Rheumatoid Factor IgA ELISAEIA-3586EIA-35862023-08-25
00840239035875Anti-Cardiolipin IgG/IgM ELISAEIA-3587EIA-35872023-08-25

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