DFH

Product Code: DFH

Products Classified as DFH

Kappa, Antigen, Antiserum, Control

Immunoglobulin (light Chain Specific) Immunological Test System.

Total Product Life Cycle (TPLC) Devices

Kappa, Antigen, Antiserum, Control

Immunoglobulin (light Chain Specific) Immunological Test System.

FDA Consensus Standards

Kappa, Antigen, Antiserum, Control [14932]

21 CFR §866.5550 🔎

Pre-market Notifications for DFH

K220001	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	Diazyme Laboratories Inc.
K212379	N Latex FLC Kappa, N Latex FLC Lambda	Siemens Healthcare Diagnostics Products GmbH
K211648	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay	Diazyme Laboratories Inc.
K210623	FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2	Sebia
K201496	N Latex FLC Kappa, N Latex FLC Lambda	Siemens Healthcare Diagnostics Products GmbH
K193047	N Latex FLC Kappa, N Latex FLC Lambda	Siemens Healthcare Diagnostics Products GmbH
K190879	N Latex FLC Kappa, N Latex FLC Lambda	Siemens Healthcare Diagnostics Products GmbH
K182098	N Latex FLC Kappa Assay, N Latex FLC Lambda Assay	Siemens Healthcare Diagnostics Products GmbH
K181438	Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay	Diazyme Laboratories Inc.
K173732	Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit	The Binding Site Group Ltd
K171742	N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL2	Siemens Healthcare Diagnostics Products GmbH
K153394	Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator	Diazyme Laboratories
K150658	Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit	THE BINDING SITE GROUP LTD
K120056	HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER	THE BINDING SITE GROUP LTD
K083602	KAPPA LIGHT CHAINS	SENTINEL CH. SpA

Global Unique Device Identification Database

00630414237473	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00630414167657	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768031465	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768031458	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768031441	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768031434	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768024436	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768012709	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768012686	KAPPA, ANTIGEN, ANTISERUM, CONTROL
00842768006357	KAPPA, ANTIGEN, ANTISERUM, CONTROL
05700572000884	KAPPA, ANTIGEN, ANTISERUM, CONTROL
05700572000693	KAPPA, ANTIGEN, ANTISERUM, CONTROL
05051700019866	Kappa, Antigen, Antiserum, Control
05051700019651	Kappa, Antigen, Antiserum, Control
05051700017794	Kappa, Antigen, Antiserum, Control

Maude Adverse Events

N LATEX FLC KAPPA	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2019-11-07
N LATEX FLC KAPPA	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2019-10-17
N ANTISERUM TO HUMAN-IG/L-CHAIN, TYPE KAPPA	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2019-08-20
N LATEX FLC KAPPA	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2019-07-08
BN II SYSTEM	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2019-05-02
N ANTISERUM TO HUMAN-IG/L-CHAIN, K TYPE	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH	2017-05-17

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