FDA.reportPublic FDA data

Candida albicans IgG ELISA

Primary DI
00404847434583
Brand
Candida albicans IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
N/A
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00404847434583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00404847434583004048474345834048474345830404847434583

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
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

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
04048474034585Candida 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