← Back to catalogue

Atellica IM CsA MCM

FDA UDI

Class I (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM CsA MCM FDA UDI
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control FDA UDI
Device Name
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL FDA UDI
Model / Reference
10995551 FDA UDI
Description
Cyclosporine (CsA) Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL FDA UDI

Identifiers

Catalog Number
10995551 FDA UDI
Primary DI / UDI-DI
00630414598758 FDA UDI
510(k) Number
K092993 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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: Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control

Atellica IM CsA MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, control.

Cleared under the same submission

K092993 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI c64b7867-0f9c-4532-af03-b0d572b33537 37 fields · synced Jun 8, 2026