FDA.reportPublic FDA data

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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSGCANDIDA SPECIES, ANTIBODY DETECTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSGCandida Species, Antibody DetectionMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474034585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474034585040484740345854048474034585

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10634853000206Fungal SerologyMICROBIOLOGICS INC.LSG2022-09-26
10634853000213Fungal SerologyMICROBIOLOGICS INC.LSG2022-09-26
00404847434583Candida albicans IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSG2019-06-05
00840239034588Candida albicans IgG ELISADRG International IncLSG2019-03-20
04049016067771Anti-Candida albicans IFA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067788Anti-Candida albicans IFA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067795Anti-Candida albicans IFA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067801Anti-Candida albicans IFA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067856Anti-Candida albicans IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067863Anti-Candida albicans IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067870Anti-Candida albicans IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067887Anti-Candida albicans IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016081715Anti-Candida albicans IFA (IgA)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-10-10
04049016067818Anti-Candida albicans IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-09-24
04049016067825Anti-Candida albicans IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-09-24
04049016067832Anti-Candida albicans IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-09-24
04049016067849Anti-Candida albicans IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLSG2016-09-24
00816387020223IMMYImmuno-Mycologics, Inc.LSG2016-09-24
00816387020230IMMYImmuno-Mycologics, Inc.LSG2016-09-24
00816387020797IMMYImmuno-Mycologics, Inc.LSG2016-09-24