FDA UDI
In Commercial Distribution
🇺🇸 United States
Affymetrix
DI: 00856826006166
·
Model: 902111
·
Affymetrix, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Affymetrix
- Primary DI
- 00856826006166
- Version / Model
- 902111
- Catalog Number
- 902111
- Company Name
- Affymetrix, Inc.
- Labeler DUNS
- 804682573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2025-02-12
- Public Version Status
- Update
- Public Device Record Key
- a2b85659-1541-473d-9e79-44a0051a3b80
Device Description
CytoScan™ Dx Post-PCR 15-30°C MOD E PW
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFX | System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection | Immunology | 866.5920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62428 | Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative detection of genome copy number variations (CNV) associated with intellectual disability, developmental delay, congenital anomalies, and/or dysmorphic features, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856826006166 | GS1 |