FDA.reportPublic FDA data

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 andsemiquantitative 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

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
00840239034588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239034588008402390345888402390345880840239034588

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Total Volume2Milliliter
Total Volume14Milliliter
Total Volume20Milliliter
Total Volume30Milliliter
Total Volume100Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840239041173ANA Detect ELISAEIA-4117EIA-41172023-08-25
00840239035622ANA-8-Screen ELISAEIA-3562EIA-35622023-08-24
00840239035639ANA-8-Profile ELISAEIA-3563EIA-35632023-08-24
00840239027733ANA Screen IgG ELISA EIA-2773EIA-27732023-08-23
00840239035899Anti-Cardiolipin Screen ELISAEIA-3589EIA-35892023-08-25
00840239035967c-ANCA (PR3) ELISAEIA-3596EIA-35962023-08-25
00840239036025Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-25
00840239059673Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-08-26
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-08-26
00840239027931Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-24
00840239027948Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-24
00840239027962EBV-EA IgG ELISAEIA-2796EIA-27962023-08-24
00840239028150H. Pylori IgG ELISA EIA-2815EIA-28152023-08-24
00840239033710Gliadin IgG ELISA EIA-3371EIA-33712023-08-24
00840239034670Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-24
00840239034731Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-24
00840239035523HGH (Human Growth Hormone) ELISAEIA-3552EIA-35522023-08-24
00840239035615Anti TPO Ab ELISAEIA-3561EIA-35612023-08-24
00840239035646Anti-dsDNA IgM ELISAEIA-3564EIA-35642023-08-24

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
00404847434583Candida albicans IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLSG2019-06-05
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