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Grifols Diagnostic Solutions Inc.

United States·US-MF-000004304

Last updated September 17, 2026

About

Grifols Diagnostic includes innovative products to support transfusion medicine, clinical diagnostics, and clinical testing services. Get to know us!

From the manufacturer's own website. Source

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Device	Model / Reference	Registries	Class	Status
Smac Replacement Reagents, Wetting Agent	K800670	FDA 510(k)	N/A	Active
Reagents For Determ. Alkaline Phosphatas	K800679	FDA 510(k)	Class II	Active
Smac Replacement Reagents-Wash Solutions	K800671	FDA 510(k)	N/A	Active
Reagents For Determ. Total Bilirubin	K800675	FDA 510(k)	Class II	Active
Reagents For Determ. Sodium In Human Sum	K800676	FDA 510(k)	Class II	Active
Quick-Check Ii Reagent Strip	K921825	FDA 510(k)	Class II	Active
Smac Replacement Reagents/Of Bun-Serum	K800673	FDA 510(k)	Class II	Active
Reagent For Determ. Chloride In Human/Sm	K800683	FDA 510(k)	Class II	Active
Smac Replacement/Total Protein Human Ser	K800674	FDA 510(k)	Class II	Active
Reagent For Determ. Glucose In H/Serum	K800687	FDA 510(k)	Class II	Active
Reagent For Determ. Potassium/In Human	K800692	FDA 510(k)	Class II	Active
Procleix Auto Detect Reagents	9053575	EUDAMED	Class A	Active
Procleix Reagent Equilibration System	741597	EUDAMED	Class A	Active
Procleix Parasite Transport Medium	9051577	EUDAMEDFDA UDI	Class A	Active
Procleix Xpress System	718431	EUDAMEDFDA UDI	Class A	Active
Procleix Auto Detect Reagents	303345	EUDAMEDFDA UDI	Class A	Active
Procleix Reagent Preparation Incubator 250	740820	EUDAMED	Class A	Active

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