FDA.reportPublic FDA data

IH-Card AHG Anti-IgG

Primary DI
07611969964857
Brand
IH-Card AHG Anti-IgG
Company
Bio-Rad Medical Diagnostics GmbH
Model
813422100
Catalog number
813422100
Device description
Anti-Human Globulin Anti-IgG; Gel card for use with the IH-system; Card for direct and indirect antiglobulin test; 288 cards of 6 microtubes
Published
2017-01-20
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
07611969964857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611969964857076119699648577611969964857

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Upright position
Storage Environment Temperature18 Degrees Celsius25 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

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