FDA.report

Candida albicans IgG ELISA

Primary DI
04048474034585
Brand
Candida albicans IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-3458
Catalog number
EIA-3458
Device description
The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.
Published
2019-06-05
Public version status
Update
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
LSGCANDIDA SPECIES, ANTIBODY DETECTION

Product Code Classifications

CodeDeviceSpecialtyClass
LSGCandida Species, Antibody DetectionMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048474034585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048474034585040484740345854048474034585

GMDN Terms

TermDefinition
Candida albicans immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to the yeast Candida albicans 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
+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
false
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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