Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED appears in FDA device records in LLANBERIS Wales, GB. FDA records list 23 510(k) clearances between and , 69 PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 23 510(k) clearances for Siemens Healthcare Diagnostics Products Limited between 2016 and 2024. The busiest year on record is 2016, with 5. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 5 |
| 2017 | 3 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | QLU | Substantially Equivalent | |
| K233946 | IMMULITE® 2000 BR-MA | MOI | Substantially Equivalent | |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | CFN | Substantially Equivalent | |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | LTK | Substantially Equivalent | |
| K220728 | vWF Ag | GGP | Substantially Equivalent | |
| K212559 | CardioPhase® hsCRP | NQD | Substantially Equivalent | |
| DEN200067 | INNOVANCE VWF Ac | QTY | Unknown | |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | CGR | Substantially Equivalent | |
| K202826 | IMMULITE® 2000 Cortisol | CGR | Substantially Equivalent | |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | DFH | Substantially Equivalent | |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | DFH | Substantially Equivalent | |
| K181525 | INNOVANCE Free PS Ag | GGP | Substantially Equivalent | |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | DFH | Substantially Equivalent | |
| K172333 | Sysmex CS-5100 | JPA | Substantially Equivalent | |
| K171072 | N Latex Cystatin C; N Protein Standard UY | NDY | Substantially Equivalent | |
| K162688 | Sysmex CS-2100i | JPA | Substantially Equivalent | |
| K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | Substantially Equivalent | |
| K161317 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | JPA | Substantially Equivalent | |
| K161312 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | Substantially Equivalent | |
| K151259 | Sysmex Automated Blood Coagulation Analyzer CS-2100i | JPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002806944 | 3002806944 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED | GLYN RHONWY, LLANBERIS Wales LL55 4EL GB | 2026 | and 75 more, listed in full below |
| 9610806 | 3001644026 | Siemens Healthcare Diagnostics Products GmbH | 76 EMIL-VON-BEHRING STRASSE, MARBURG Hesse 35041 DE | 2026 | and 70 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- GFOActivated Partial Thromboplastin
- DCFAlbumin, Antigen, Antiserum, Control
- DFJAlbumin, Rhodamine, Antigen, Antiserum, Control
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control
- DCOAlpha-Globulin, Antigen, Antiserum, Control
- DDBCeruloplasmin, Antigen, Antiserum, Control
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- DKZEnzyme Immunoassay, Amphetamine
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DBFFerritin, Antigen, Antiserum, Control
- DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
- GFKFibrinogen Determination Standards And Controls
- GFXFibrinogen Standard
- DADHaptoglobin, Antigen, Antiserum, Control
- CZXHemopexin, Antigen, Antiserum, Control
- CZPIga, Antigen, Antiserum, Control
- DGCIge, Antigen, Antiserum, Control
- DGOIge, Peroxidase, Antigen, Antiserum, Control
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- CHNImmunochemical, Ceruloplasmin
- DFHKappa, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- DDRMyoglobin, Antigen, Antiserum, Control
- DDXPlasminogen, Antigen, Antiserum, Control
- CDDRadioassay, Vitamin B12
- CKGRadioimmunoassay, Acth
- CIZRadioimmunoassay, Androstenedione
- CGRRadioimmunoassay, Cortisol
- CGTRadioimmunoassay, Cyclic Gmp
- CHPRadioimmunoassay, Estradiol
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CGCRadioimmunoassay, Gastrin
- CFLRadioimmunoassay, Human Growth Hormone
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)
- CFPRadioimmunoassay, Immunoreactive Insulin
- CEPRadioimmunoassay, Luteinizing Hormone
- CEWRadioimmunoassay, Parathyroid Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDPRadioimmunoassay, Total Triiodothyronine
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- DCNSystem, Test, C-Reactive Protein
- DCHSystem, Test, C-Reactive Protein, Rhodamine
- DHXSystem, Test, Carcinoembryonic Antigen
- DHASystem, Test, Human Chorionic Gonadotropin
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2966-2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. | Class II | Open, Classified | |
| Z-2965-2026 | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly | Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Siemens Healthcare Diagnostics Products Limited edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain