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Atellica IM Rub M

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM Rub M FDA UDI
Generic Name
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Rubella IgM (Rub M) Atellica IM - RGT 50T FDA UDI
Model / Reference
10995668 FDA UDI
Description
Rubella IgM (Rub M) Atellica IM - RGT 50T FDA UDI

Identifiers

Catalog Number
10995668 FDA UDI
Primary DI / UDI-DI
00630414599830 FDA UDI
510(k) Number
K010668 FDA UDI
FDA Product Code
LFX FDA UDI
GMDN Term
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3510 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

Atellica IM Rub M by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K010668 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI a5f2c92a-48f0-4814-b97b-93d3fa05a4c6 37 fields · synced May 29, 2026