ORTHO® Rh
ORTHO - 715480
Device Description
A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DGR
Device Name: Whole Human Serum, Antigen, Antiserum, Control
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.5700
Third Party Flag: N
Medical Specialty: IM
Device IdentifiersDevice Id: 10758750003419
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A