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
PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

GMDN Terms

Code Name
62428 Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

Identifiers

Type ID
Primary 00856826006166