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Panels › Immunology › Product code CZP · Class 2

Iga, Antigen, Antiserum, Control

Regulation 866.5510

0510(k)s in 12 months (54 all time)

0recalls in 12 months (3 all time)

3recalls that name a 510(k)

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Top companies in CZP

Company	510(k)s	Recalls
Abbott Laboratories	3	1
Boehringer Mannheim Corp.	3	0
Kallestad Laboratories, Inc.	3	0
Atlantic Antibodies	2	0
Dako Corp.	2	0
E.I. Dupont DE Nemours & Co., Inc.	2	0
Helena Laboratories	2	0
Icl Scientific	2	0
Instrumentation Laboratory CO	2	0
Randox Laboratories, Ltd.	1	1

Date	Firm and product	Code	Linked 510(k)
Dec 3, 2022	Randox Laboratories Ltd. IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832 Terminated	CZP	K955794
Jun 3, 2019	Roche Diagnostics Corporation The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically. Terminated	CZP	K040435
May 16, 2018	Abbott Laboratories, Inc Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, f Terminated	CZP	K983359

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