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Company · GB

Immunodiagnostics Systems Ltd

FDA 510(k) clearances and medical device recalls filed under this name, 2026 to 2026. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (1 in 12 months)

8recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	3
NEO	System, Test, Osteocalcin	2
JIT	Calibrator, Secondary	1
JMM	Column Chromatography & Color Development, Hydroxyproline	1
LLL	Extractable Antinuclear Antibody, Antigen And Control	1
MRG	System, Test, Vitamin D	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 21, 2026	K253817	IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La Immunodiagnostics Systems Limited, GB	LLL

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Contro Terminated	JIT	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS Intact PINP, Catalog Number IS-4000. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) assay is intended Terminated	CIN	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Terminated	NEO	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2900. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Assay is intended for the quantitative determination of Osteoca Terminated	NEO	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP (IDS-iSYS BAP) Control Set is used fo Terminated	CIN	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS-iSYS Ostase BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase BAP Assay (IDS-iSYS BAP) is intended for the quantita Terminated	CIN	None listed
Oct 10, 2012	Immunodiagnostics Systems Ltd IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantificat Terminated	JMM	None listed
Oct 24, 2008	Immunodiagnostics Systems Inc IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma. Ref: AC-57F1 Lot 60897 Exp 2009-08; Terminated	MRG	K021163

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