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binx io

FDA UDI

Class II (US FDA UDI)

by Binx Health, Inc.

Identity

Trade Name
binx io FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI
Device Name
binx io instrument FDA UDI
Model / Reference
V1 FDA UDI
Description
binx io instrument FDA UDI

Identifiers

Catalog Number
3.001.001 FDA UDI
Primary DI / UDI-DI
05060441760005 FDA UDI
510(k) Number
K200533 FDA UDI
FDA Product Code
NSU FDA UDI
GMDN Term
Thermal cycler nucleic acid amplification analyser IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Thermal cycler nucleic acid amplification analyser IVD, point-of-care

binx io by Binx Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thermal cycler nucleic acid amplification analyser IVD, point-of-care.

Cleared under the same submission

K200533 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Binx Health, Inc.

Sources (1)

  • FDA UDI 09a3696e-071e-40ef-9638-024cfaed41c5 35 fields · synced Jun 8, 2026