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

Emit Qst Primidone Assay Ref K840939

Syva Emit Ii Plus Phencyclidine Assay, Model 9J029UL Ref K993983

Emit D.A.V. Methaqualone Urine Calibra Ref K822052

Vista B12 Assay Ref K941235

Advance Emit Cad Procainamide Assay Ref K823128

Advance Emit-Cad Quinidine Assay Ref K822588

Emit Desipramine Assay Ref K861155

Theophylline Assay To The Centrifichem Ref K780441

Syva Microtrak Chlamlydia Eia, Modification Ref K905179

Emit (R) Ii Calibrator A Level 1 (Cutoff) 2 (High) Ref K904764

Syva Microtrak Eia Accessory Reagents Ref K903758

Emit-St Serum Phenobarbital Assay Ref K811621

Emit Caffeine Assay Ref K853872

Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109UL Ref K011878

Microtrak Chlamydia Tracho. Test - Methanol Fixat. Ref K872903

Emit Convenience Pack: Thyroxine Assay Ref K881357

Syva Emit Ii Plus Methaqualone Assay, Model 9Q029UL/9Q129UL Ref K993986

Emit(R) 2000 Gentamicin Assay/Calibrators Ref K913410

Emit Imipramine Assay Ref K844951

Emit(R) D.A.U. Barbiturate Assay Ref K931535

Vista Folate Assay Ref K934121

Advance System Emit-Amd Tobramycin Cntrl Ref K820129

Collection Kit Chlamydia Trachomatis Ref K832079

Emit Qst Amikacin Assay Ref K840193

Cyberlab High Volume Drug Testing System Ref K892060

Emit 700 Barbiturate Assay Ref K843418

Revised Labeling For Syva Methadone Assays Ref K873899

Syva Emit Ii Plus Cannabinoid Assay, Models 9N029UL/9N129UL Ref K993984

Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 Ref K993755

Acculevel Carbamazepine Test Ref K871254

Syva Emit Ii Plus Propoxyphene Assay, Models 9G029UL/9G129UL Ref K993981

Emit Iic Cannabinoid Assay Ref K940158

Emit D.A.U. Urine Cannabinoid Calibra Ref K834457

Vista Thyroxine Uptake Assay Ref K923676

Emit-St Cannabinoid Calibrator Ref K812197

Emit Qst Theophylline Assay Ref K831272

Emit(R) Iic Amphetamine Assay Ref K935352

Emit Aed Phenytoin Assay Ref K832033

Emit T-Uptake Assay Thyroid Hormone Binding Ratio Ref K880619

Emit Column Digoxin Calibrators Ref K861395

Micro Trak Chlamydia Trachomatis Direct Ref K832077

Emit(R) Ii Cannabinoid 20 Ng Assay Ref K904570

Emit Qst Tobramycin Assay Ref K831416

Analyzer, Emit Aed Assays To Centrifiche Ref K780218

Vista(R) Human Luteinizing Hormone(Hlh) Assay Ref K926394

Microtrak Chlamydia Trachomatis Direct Speci. Test Ref K864888

Analyzer-Supplement, Kinetic, Lkb 2086 Ref K780461

Emit-Stm Barbiturate Assay Ref K802617

Emit-Aad Theophylline Control Ref K813241

Emit Serum Tricyclic Antidepress. Contro Ref K831979