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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

A52735 — IVDR Class A IVDR by Thermo Fisher…

MD Atlas
Thermo Fisher Scientific Baltics UAB

EUDAMED last updated this device on Mar 23, 2026

A52735

0190302MagMAXDxDN

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Thermo Fisher Scientific Baltics UAB
UDI-DI code: 10190302019170
Reference / catalog number: A52735

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View device family (Basic UDI)

Manufacturer information

Organization name: Thermo Fisher Scientific Baltics UAB
SRN: LT-MF-000046574
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

22 warnings recorded — scroll inside the panel to see all entries.

CW082
Causes skin irritation.
CW085
Causes serious eye irritation
CW166
Avoid release to the environment
CW162
Wash hands thoroughly after handling
CW167
Wear protective gloves/protective clothing/eye protection/face protection
CW163
Do not eat, drink or smoke when using this product
CW175
IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician
CW422
IF ON SKIN: Wash with plenty of soap and water
CW999
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
CW999
P330 - Rinse mouth
CW081
Causes severe skin burns and eye damage
CW106
Harmful to aquatic life with long lasting effects
CW158
Do not breathe dust/fume/gas/mist/vapours/spray
CW999
P303 + P361 + P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower
CW999
P310 - Immediately call a POISON CENTER or doctor/physician
CW159
Avoid breathing dust/fume/gas/mist/vapours/spray
CW401
P304 + P340 - IF INHALED: Remove person to fresh air and keep comfortable for breathing
CW999
P301 + P330 + P331 - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting
CW089
May cause allergy or asthma symptoms or breathing difficulties if inhaled
CW171
In case of inadequate ventilation wear respiratory protection
CW185
If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician
CW076
Harmful if swallowed.

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Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement	Apr 16, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 10190302019170
Basic UDI-DI: 0190302MagMAXDxDN
Reference / catalog number: A52735
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The Applied Biosystems™ MagMAX™ Dx Viral/Pathogen NA Isolation Kit (A52735) is a magnetic bead technology nucleic acid purification kit intended for the isolation and purification of viral and bacterial nucleic acid from human respiratory biological specimen for qPCR downstream application. The kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of automated magnetic bead purification and in vitro diagnostic procedures.
Additional information URL: https://thermofisher.com/MVPDx-IFU
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)10190302019170

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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