IgE for the quantitative determination of Immunoglobulin E (IgE) concentration in human serum. For in vitro diagnostic use only. 96 Tests.
Pointe Scientific, Inc. - P1035-96
Device Description
A collection of reagents and other associated materials intended to be used for the quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.
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: DGC
Device Name: Ige, Antigen, Antiserum, Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5510
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00811727013330
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