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Glenner'S Stain Suppliers

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Rowley Biochemical Inc. | Address: 10 Electronics Avenue, Danvers, Massachusetts 01923, USA USA
www.rowleybio.com | Send Inquiry | Phone: +1-(978)-739-4883
FDA Registration: 1219125  Annual Revenues: < USD 1 Million
Products: Chemical Supplies, General Medical Supplies, General Diagnostics, General Examination Supplies, Stain Sets & Solutions, Eosin Y Stain (FDA Code: HYB), ...
Rowley Biochemical Inc. supplies biochemical research facilities, university and clinical laboratories with quality in-vitro stains and reagents. We offer quality dyes, stains & biochemical reagents r more...
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 EMAIL INQUIRY to  1 Glenner'S Stain suppliers  
FDA Code / Regulation: HYG / 864.1850

Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.

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