DEVICE: IH-Card AHG Anti-IgG (07611969964857)

Download: XML | JSON

Device Identifier (DI) Information

IH-Card AHG Anti-IgG
813422100
813422100
Bio-Rad Medical Diagnostics GmbH
07611969964857
GS1
1
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
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Polyspecific antihuman globulin IVD, antibody, agglutination One 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Upright position
Storage Environment Temperature: between 18 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
January 20, 2017

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-224-6723
techsupport.bmd@bio-rad.com
CLOSE