← Back to catalogue

Dimension® Flex® reagent cartridge SIRO

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge SIRO FDA UDI
Generic Name
Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Sirolimus Flex® reagent cartridge, 80 tests FDA UDI
Model / Reference
10464331 FDA UDI
Description
Sirolimus Flex® reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number
DF306 FDA UDI
Primary DI / UDI-DI
00842768022111 FDA UDI
510(k) Number
K081857 FDA UDI
FDA Product Code
NRP FDA UDI
GMDN Term
Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3840 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: Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge SIRO by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rapamycin (sirolimus) therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K081857 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 8dc7334a-5a34-4eb9-965c-1f36ad980831 37 fields · synced Jun 6, 2026