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
04048474040876GAD65 Ab ELISAEIA-4087EIA-40872024-12-02
04048474012880FSH ELISAEIA-1288EIA-12882024-11-22
04048474012897LH-Serum ELISAEIA-1289EIA-12892024-11-22
04048474012903LH-Urine ELISAEIA-1290EIA-12902024-11-22
04048474012910Prolactin ELISAEIA-1291EIA-12912024-11-22
04048474012934C-Peptide ELISAEIA-1293EIA-12932024-11-22
04048474015591Testosterone ELISAEIA-1559EIA-15592024-11-22
04048474015614Progesterone ELISAEIA-1561EIA-15612024-11-22
04048474015621DHEA-S ELISAEIA-1562EIA-15622024-11-22
04048474016123Free Estriol ELISAEIA-1612EIA-16122024-11-22
04048474018264Sperm Antibody ELISAEIA-1826EIA-18262024-11-22
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474023961TGF-Beta 2 ELISAEIA-2396EIA-23962024-11-22
04048474027754RF IgM (Rheumatoid Factor) ELISAEIA-2775EIA-27752024-11-22
04048474046632Progesterone (serum) ELISACLA-4663CLA-46632024-11-21
04048474046649Estradiol (serum) ELISACLA-4664CLA-46642024-11-21
0404847401292717 OH-Progesterone ELISAEIA-1292EIA-12922024-11-18
04048474023855Free Triiodothyronine (fT3) ELISAEIA-2385EIA-23852024-09-23
04048474038019Free T3 ELISAEIA-3801EIA-38012024-09-23
04048474053562T3 freeHYE-5356HYE-53562024-09-23

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