BP 230 ELISA TEST

Primary DI
B110RGM7613D0
Brand
BP 230 ELISA TEST
Company
Bion Enterprises, Ltd.
Model
RG-M7613-D
Catalog number
RG-M7613-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
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071961000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071961000MESACUP MODELS BP180 AND BP230 ELISA KITSMbl International Corporation2008-08-25OEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B110RGM7613D0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bullous pemphigoid antigen 1 (BPAG1) 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 bullous pemphigoid antigen 1 (BPAG1), also known as BP230, in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of the autoimmune skin disease bullous pemphigoid.

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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