FDA.reportPublic FDA data

DSG 1 & DSG 3 ELISA TEST

Primary DI
B110RGM7593D0
Brand
DSG 1 & DSG 3 ELISA TEST
Company
Bion Enterprises, Ltd.
Model
RG-M7593-D
Catalog number
RG-M7593-D
Published
2016-09-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBOAutoantibodies,Skin(Desmoglein 1 And Desmoglein 3)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000336000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000336000RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 ERhigene, Inc.2000-06-09NBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110RGM7593D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Desmoglein 1 (DSG1)/desmoglein 3 (DSG3) 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 antibodies to desmoglein 1 (DSG1) and desmoglein 3 (DSG3) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune pemphigus skin diseases pemphigus foliaceus and pemphigus vulgaris.

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
847-544-5044bion@mblintl.com

Regulatory Flags#

DUNS number
024824641
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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B110CAL10900ANA CalibratorCAL-1090CAL-10902016-09-12
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B110AN10060Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test SystemAN-1006AN-10062016-09-12
B110AN10120Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test SystemAN-1012AN-10122016-09-12
B110AN10160Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test SystemAN-1016AN-10162016-09-12
B110AND1800I0ANA (HEp-2) Test System, 1800 TestsAND-1800 IAND-1800 I2016-09-12
B110ANK1200ANA (HEp-2) Test System, 120 TestsANK-120ANK-1202016-09-12
B110ANK600ANA (HEp-2) Test System, 60 TestsANK-60ANK-602016-09-12
B110ANN10100ANA Negative ControlANN-1010ANN-10102016-09-12
B110ANP10400ANA Homogeneous ControlANP-1040ANP-10402016-09-12
B110NUC10420ANA Nucleolar ControlNUC-1042NUC-10422016-09-12
B110RNP10440ANA RNP ControlRNP-1044RNP-10442016-09-12
B110SCL10460ANA Scl-70 ControlSCL-1046SCL-10462016-09-12
B110SSA10450ANA SSA ControlSSA-1045SSA-10452016-09-12
B110SSB10470ANA SSB ControlSSB-1047SSB-10472016-09-12
B110QRP63140Respiratory Virus Panel Antigen Control Slide, 14 wellsQRP-6314QRP-63142016-09-12
B110QCH41020Chlamydia Antigen Control Slide, 2 wellsQCH-4102QCH-41022016-09-12
B110MUG600Mumps IgG Test System, 60 TestsMUG-60MUG-602016-09-12
B110NA51400EBNA Positive ControlNA-5140NA-51402016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987506017434DSG-1 & DSG-3 ELISA Test SystemMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.NBO2023-08-04
04987506015942DSG-1 & DSG-3 ELISA Test SystemMEDICAL & BIOLOGICAL LABORATORIES CO., LTD.NBO2020-02-17
04049016089186Anti-Desmoglein 1 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBO2016-09-24
04049016089193Anti-Desmoglein 3 ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGNBO2016-09-24