FDA.report

Adenovirus Antigen (stool) ELISA

Primary DI
04048474034448
Brand
Adenovirus Antigen (stool) ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3444
Catalog number
EIA-3444
Device description
The Adenovirus Stool Antigen Detection ELISA is an in vitro procedure for the qualitative determination of adenovirus antigen in feces.
Published
2023-08-29
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
GNYAntisera, Fluorescent, Adenovirus 1-33

Product Code Classifications

CodeDeviceSpecialtyClass
GNYAntisera, Fluorescent, Adenovirus 1-33Microbiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048474034448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048474034448040484740344484048474034448

GMDN Terms

TermDefinition
Adenovirus antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Adenovirus 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
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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