DAS

Product Code: DAS

Products Classified as DAS

2907

Igg (fc Fragment Specific), Antigen, Antiserum, Control

Immunoglobulin G (Fc Fragment Specific) Immunological Test System.

Total Product Life Cycle (TPLC) Devices

2907

Igg (fc Fragment Specific), Antigen, Antiserum, Control

Immunoglobulin G (Fc Fragment Specific) Immunological Test System.

FDA Consensus Standards

• Igg (Fc Fragment Specific), Antigen, Antiserum, Control [14932]: 21 CFR §866.5530 🔎

Pre-market Notifications for DAS

K982023	PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT	INOVA DIAGNOSTICS, INC.
K944876	HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT	RESEARCH DIAGNOSTICS, INC.
K943205	HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)	RESEARCH DIAGNOSTICS, INC.
K943098	HUMAN IGG SUBCLASSES ELISA COMBI KIT	RESEARCH DIAGNOSTICS, INC.
K790708	ANTISERUM TO HUMAN IG G FC FRAGMENTS	KENT LABORATORIES, INC.
K790715	ANTISERUM TO HUMAN FC	KENT LABORATORIES, INC.

Global Unique Device Identification Database

• 00842768006708: IGG (FC FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL
• 00842768006692: IGG (FC FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL
• 00842768008467: IGG (FC FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL
• 00842768008450: IGG (FC FRAGMENT SPECIFIC), ANTIGEN, ANTISERUM, CONTROL