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Eonis SCID-SMA kit

FDA UDI

Class II (US FDA UDI)

by Wallac, Inc.

Identity

Trade Name
Eonis SCID-SMA kit FDA UDI
Generic Name
Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs. FDA UDI
Model / Reference
3242-001U FDA UDI
Description
The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs. FDA UDI

Identifiers

Catalog Number
3242-001U FDA UDI
Primary DI / UDI-DI
06438147377756 FDA UDI
510(k) Number
DEN200044 FDA UDI
K203035 FDA UDI
FDA Product Code
QUE FDA UDI
PJI FDA UDI
GMDN Term
Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5980 FDA UDI
866.5930 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT)

Eonis SCID-SMA kit by Wallac, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple inborn immunodeficiency/muscular/haematological disorder IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

DEN200044 also covers:

K203035 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA UDI 3a56719e-cdde-49e1-b88b-6c7fd55bfcad 36 fields · synced May 30, 2026