FDA.report

Candida albicans IgG ELISA

Primary DI
00840239034588
Brand
Candida albicans IgG ELISA
Company
DRG International Inc
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
2019-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LSGCANDIDA SPECIES, ANTIBODY DETECTION

Product Code Classifications

CodeDeviceSpecialtyClass
LSGCandida Species, Antibody DetectionMicrobiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840239034588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239034588008402390345888402390345880840239034588

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.

Device Sizes

TypeValueUnit
Total Volume100Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags

DUNS number
075150847
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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