FDA.reportPublic FDA data

Aspergillus fumigatus IgG ELISA

Primary DI
00840239061294
Brand
Aspergillus fumigatus IgG ELISA
Company
DRG International Inc
Model
EIA-6129
Catalog number
EIA-6129
Device description
The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
Published
2023-08-26
Public version status
New
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
JWTAntigen, Cf, Aspergillus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWTAntigen, Cf, Aspergillus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239061294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239061294008402390612948402390612940840239061294

GMDN Terms#

Term, Definition table
TermDefinition
Aspergillus fumigatus 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 fungus Aspergillus fumigatus 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
1 973-564-7555corpoffice@drg-international.com

Regulatory Flags#

DUNS number
075150847
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
04048474061291Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2023-09-01
10634853000220Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000237Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000244Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000404Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
10634853000428Fungal SerologyMICROBIOLOGICS INC.JWT2022-09-26
07640158216101Aspergillus fumigatus IgG ELISABordier affinity products S.A.JWT2022-09-21
00404847425017Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2021-06-07
00404847461299Aspergillus fumigatus IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungJWT2021-06-07
00816387020001IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020025IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020049IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020056IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020063IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020087IMMYImmuno-Mycologics, Inc.JWT2016-09-24
00816387020100IMMYImmuno-Mycologics, Inc.JWT2016-09-24