FDA.reportPublic FDA data

Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific

Primary DI
07611969950652
Brand
Anti-Human-Globulin, Anti-IgG, -C3d; polyspecific
Company
Bio-Rad Medical Diagnostics GmbH
Model
804115100
Catalog number
804115100
Device description
Anti-Human-Globulin, Anti-IgG, -C3d; Polyspecific; Rabbit/Murine Monoclonal (Bric8); for tube test; 10x10ml
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611969950652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969950652076119699506527611969950652

GMDN Terms#

Term, Definition table
TermDefinition
Polyspecific antihuman globulin/complement IVD, antibody, agglutinationOne or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies and/or complement components when fixed to red blood cells. This solution is intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin and/or complement components, using an agglutination technique.

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
800-224-6723techsupport.bmd@bio-rad.com

Regulatory Flags#

DUNS number
312576506
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07611969233786IH-5000015100015102019-07-05
07611969205493IH-10000011000011002017-01-20
07611969953066Lymphoflot8240128240122015-07-06
07611969953073Lymphostabil8240208240202015-07-06
07611969953080Hanks Solution8240358240352015-07-06
07611969953172Control-HLA (pos.)8241018241012015-07-01
07611969953189Control-HLA (neg.)8241068241062015-07-01
07611969953196Control-HLA-DR (pos.)8241108241102015-07-01
07611969953257HLA-A SSP Kit8262018262012015-07-01
07611969953264HLA-B SSP Kit8262068262062015-07-01
07611969953271HLA-C SSP Kit8262128262122015-07-01
07611969953288DRB SSP Kit8262158262152015-07-01
07611969953295DQB SSP Kit8262208262202015-07-01
07611969953301ABDR SSPtray8262308262302015-07-01
07611969953318ABC SSPtray8262408262402015-07-01
07611969965700Lymphoscreen ABC-608233002018-03-08
07611969965717Lymphoscreen DR 30x28233502018-03-08
03610522165049Wash Solution A Concentrate120126682020-02-05
07611969965304Washing Solution Concentrate8480000918480000912016-03-20
03610522136421IH-AbID12010902120109022022-12-13