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Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent FDA UDI
Generic Name
Multiple immunosuppressant therapeutic drug monitoring IVD, reagent FDA UDI
Device Name
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent FDA UDI
Model / Reference
10488260 FDA UDI
Description
Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent FDA UDI

Identifiers

Catalog Number
8S079UL FDA UDI
Primary DI / UDI-DI
00842768030048 FDA UDI
510(k) Number
K083487 FDA UDI
FDA Product Code
NRP FDA UDI
MLM FDA UDI
GMDN Term
Multiple immunosuppressant therapeutic drug monitoring IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3840 FDA UDI
862.1678 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: Multiple immunosuppressant therapeutic drug monitoring IVD, reagent

Syva® Emit® 2000 Siro/Tacro Sample Pretreatment Reagent by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K083487 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 c146299c-a327-4025-ac9c-581c78225635 37 fields · synced May 31, 2026