OYU: Dna-Probe Kit, Human Chromosome
FDA product code OYU. Class II, classified under 21 CFR 866.4700. What the classification flags say about Part 820 under the QMSR.
As of Oct 26, 2026, FDA product code OYU (Dna-Probe Kit, Human Chromosome) is Class II under 21 CFR 866.4700, reviewed through 510(k), with 3 linked 510(k), De Novo or BK numbers, 0 PMAs and 1 recall product record.
Classification
- Product code
- OYU
- Device name
- Dna-Probe Kit, Human Chromosome
- Device class
- Class II
- Regulation
- 21 CFR 866.4700
- Review panel
- Pathology
- Premarket route
- 510(k)
- CGMP-exempt flag
- No
- Life-sustaining flag
- No
- Implant flag
- No
- Third-party review
- Not a candidate
- Summary malfunction reporting
- Eligible
FDA definition. Detection of alpha satellite sequences in the centromere regions of human chromosomes in conjunction with routine diagnostic cytgenetic testing. It is indicated for use as an adjunct to standard cytogenetic methaphase analysis a identifying and enumerating human chromosomes via fluorescence in situ hybridization (FISH) in metaphase cells and interphase nuclei of human cells. It is not intended to be used as a stand alone assay for test reporting or clinical diagnosis. FISH results are intended to be reported and interpreted only in conjunction with results of standard cytogenetic analysis, performed concurrently, utilizing the same patient specimen.
Data from openFDA as of 26 October 2026. Read the record on openFDA · FDA product code classification database
Part 820 requirements the flags point to
Part 820 rules for OYU
- CGMP exemptionClassification regulation, 21 CFR parts 862 to 892
- Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
- Design and development, ISO 13485 clause 7.321 CFR 820.10(c)
- Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
- Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d)
- Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
- Complaint and record content21 CFR 820.35
- Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions
These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.
Clearances and recalls on record
- 510(k), De Novo and BK numbers linked
- 3 · Search these clearances
- PMA numbers linked
- 0
- Recall product records
- 1
- Adverse event reports
- Search MAUDE for OYU
Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.
Search all 7,097 product codes, or read the guide to the Part 820 rules behind these flags.
Check your quality documents against Part 820
Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.