Syva Co.

Country not established

Devices: 448

What Syva Co. makes

Syva Co. manufactures diagnostic reagents and systems for laboratory testing, including calibrators, immunoassay controls, and solid-phase column systems for drug and metabolite analysis. Their portfolio includes assays for ethyl alcohol, cortisol, theophylline, and controlled substances like phenyclidine and methaqualone, as well as a nebulizer for aerosolized medication delivery. The company also produces a rapid one-step test for C-reactive protein (CRP).

The company’s products are regulated under FDA’s Class I, Class II, and Unclassified (U) device classifications, with many cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue448

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What Syva Co. makes

Catalogue448

Acculevel Theophylline Test Ref K844642

Emit(R) Ii Opiate Assay Ref K902577

Syva Advance Standardization Kit #3 Ref K821938

Prisma-C-Reactive Protein Calibrators Ref K823417

Emit D.A.U. Low & Med. Calibrators B Ref K842816

Emit Hva Calibrator Kit Ref K881943

Emit Aaii Thyroxine Calibrators Ref K801287

Aga Uv Photometer Ref K801499

Emit N-Acetylprocainamide Assay Ref K781378

Emit D.A.U. Monoclonal Amphetamine/Methamphetamine Ref K884022

Emit 700 Calibrator A Ref K843163

Emit Iic Calibrators Ref K935192

Vista Ultrasensitive Htsh Assay Ref K922138

Emit 2000 Digoxin Assay/Calibrators Ref K942619

Emit Digoxin Mobile Phase Solution Ref K861394

Emit(R) Ii 9 Cannabinoid Negative Calibra/Controls Ref K904569

Urine Medium Calibrator Ref K790399

Emit Auto Carousel Ref K812647

Emit Valproic Acid Assay Ref K801207

Syva Iq 190 Digital Pipetter Diluter Ref K842390

Emit D.A.U. Cocaine Assay Ref K843556

Syva 700 System Accessories-Clinical Chem Analyzer Ref K850659

Drug Detection System Ref K802619

Advance System Emit-Amd Tobramycin Assay Ref K820130

Emit Valproic Acid Control Ref K801206

Emit(R) Ii Calibrator A Level 1 & Level 2 Ref K902578

Emit-St Serum Calbrator Ref K810464

Analyzer, Fast, Centrifugal, Gemsaec Ref K780380

Emit-St Photometer & Diluter Verifica Ref K830518

Advance Sys. Emit-Aed Antiepileptic Drug Ref K823746

Emit Quinidine Assay Ref K862214

Emit Iic Phencyclidine Assay Ref K935191

Emit-St Serum Phenobarbital Calibrator Ref K811622

Emit Hva Barbiturate Assay Ref K882611

Syva Emit Ii Methadone Assay Ref K920751

Enit Aba Thyroxine Assay Ref K770070

Modifica- Of Emit Aed Ethosuximide Assay Ref K832797

Emit Theophylline Assay Ref K790256

Revised Labeling For Syva Barbiturate Assays Ref K874702

Control Set, Emit Methotrexate Ref K781827

Prisma C-Reactive Protein Assay Ref K823416

Emit Qst Carbamazepine Assay Ref K882961

Emit Valproic Acid Assay Ref K862652

Accupoint Hcg Pregnancy Test And Accessories Ref K872130

Vista Free Thyroxine Assay Ref K923572

Syva Microtrak(R) Ii Chlamydia Eia Block Reagent Ref K926090

Emit Netilmicin Assay Ref K833715

Emit(R) D.A.U Amphetamine Class Low Calibrator Ref K890451

Emit Auto Digoxin Assay Ref K790303

Emit Qst Gentamicin Assay Ref K873855