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FDA PRODUCT CODE · CLASS II

OZF — Tissue Rna Preservative For Collection, Storage, And Transportation

The human tissue RNA preservation collection, storage, and transportation tube is a single-use, prefilled container intended for the collection, storage, and transportation of fresh human tissue specimens for subsequent RNA isolation and further molecular diagnostic testing.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.4070
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
PA
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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