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Antiserum to Rabbit IgG H & L Chain

FDA 510(k)

Class II (US FDA 510(k))

510(k) K790706

by Kent Laboratories, Inc.

Identifiers

510(k) Number
K790706 FDA 510(k)
FDA Product Code
DFH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5550 FDA 510(k)
Regulation Number
866.5550 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This product is an Antiserum to Rabbit IgG Heavy and Light Chain, classified under product code DFH and DEW (Kappa Antigen, Antiserum, Control). It is a biological preparation containing antibodies specific to rabbit immunoglobulin G (IgG), including both heavy and light chains, designed for immunological applications in research or diagnostic settings.

The Antiserum to Rabbit IgG H & L Chain is supplied as a sterile, liquid formulation for laboratory use. It is intended for single-use and requires proper storage under controlled conditions to maintain efficacy. The device holds FDA 510(k) clearance (K790706) under the Immunology advisory committee and is classified as a Class II medical device under Special Controls (regulation number 866.5550).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ANTISERUM TO RABBIT IGG H & L CHAIN - fda.report, PDF K790706 - Antiserum to Rabbit Igg H & L Chain, K790702 FDA 510(k) - ANTISERUM | Kent Laboratories, Inc., Kent Laboratories | Biotech Manufacturer | Bellingham, WA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Kent Laboratories, Inc.

Sources (1)

  • FDA 510(k) K790706 24 fields · synced Sep 19, 2026