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

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

OXP is the FDA product code for Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment, a class II device type, regulated under 21 CFR 866.6010. FDA's definition for this code reads: "X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OXP
Device name
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
FDA definition
X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
Regulation
21 CFR 866.6010
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
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OXP

By decision year
1 clearance under product code OXP with a decision year between 1997 and 1997, 1997 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXP by decision year
YearClearances
19971

Applicants with the most clearances

Product code OXP
Applicants holding the most 510(k) clearances under product code OXP
ApplicantClearances
Vysis1

Companies listing this code with FDA

Companies whose registered establishments list this code