FDA.reportPublic FDA data

Anti-Candida albicans IFA (IgM)

Primary DI
04049016067887
Brand
Anti-Candida albicans IFA (IgM)
Company
EUROIMMUN Medizinische Labordiagnostika AG
Model
FI 2861-2005 M
Published
2016-10-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04049016067887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049016067887040490160678874049016067887

GMDN Terms#

Term, Definition table
TermDefinition
Candida albicans immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the yeast Candida albicans in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
322209263
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
04049016158547Anti-Measles Virus ELISA 2.0 (IgG)EI 2610-9601-2 G2026-05-29
04049016152071TITERPLANE set for the incubation of slides with 10 fieldsZZ 9999-0101-18-R2026-05-11
04049016152118Coded reagent tray for slides with 10 fieldsZZ 9999-0110-12-R2026-05-11
04049016152132Coded reagent tray for slides with 50 fieldsZZ 9999-0150-13-R2026-05-11
04049016152156Coded glass plates for the incubation of slides with 10 fieldsZZ 9999-0510-15-R2026-05-11
04049016152163Coded glass plates for the incubation of slides with 50 fieldsZZ 9999-0550-16-R2026-05-11
04049016155638Incubation tray 44 channels, blackZD 9892-30442026-05-11
04049016151302FITC-labelled anti-human IgA with Evans BlueAF 601-0540-R2026-03-04
04049016151319FITC-labelled anti-human IgG with Evans BlueAF 602-0540-R2026-02-10
04049016151647FITC-labelled anti-human IgG with Evans BlueAF 602-0546-R2026-02-10
04049016026976ANA Screen ELISA (IgG)EA 1590-9601-8 G2016-09-24
04049016045335ANA IFA: HEp-20-10FA 1522-10032016-09-24
04049016045342ANA IFA: HEp-20-10FA 1522-10052016-09-24
04049016045359ANA IFA: HEp-20-10FA 1522-10102016-09-24
04049016045366ANA IFA: HEp-20-10FA 1522-10502016-09-24
04049016045380ANA IFA: HEp-20-10FA 1522-20032016-09-24
04049016045397ANA IFA: HEp-20-10FA 1522-20052016-09-24
04049016045403ANA IFA: HEp-20-10FA 1522-20102016-09-24
04049016099017IFA 40: HEp-20-10FA 1522-1010-12016-09-24
04049016099024IFA 40: HEp-20-10FA 1522-2005-12016-09-24

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
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
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