510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OZFClass II

Tissue Rna Preservative For Collection, Storage, And Transportation

21 CFR 866.4070 / Immunology
FDA source (opens on fda.gov)

OZF is the FDA product code for Tissue Rna Preservative For Collection, Storage, And Transportation, a class II device type, regulated under 21 CFR 866.4070. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OZF
Device name
Tissue Rna Preservative For Collection, Storage, And Transportation
FDA definition
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.
Regulation
21 CFR 866.4070
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OZF

By decision year
1 clearance under product code OZF with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OZF by decision year
YearClearances
20121

Applicants with the most clearances

Product code OZF
Applicants holding the most 510(k) clearances under product code OZF
ApplicantClearances
Asuragen, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code