Anti-ER - MU368-100
Device Description
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of estrogen (oestrogen) and/or progesterone receptors in a clinical specimen.
Environmental Conditions
- Store at 2-8°c
Device Sizes
- Total Volume: 0.1 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MYA
Device Name: Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: PA
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: 864.1860
Third Party Flag: Y
Medical Specialty: HE
Device IdentifiersDevice Id: 00850646007150
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