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Syva® Emit® 2000 Vancomycin Calibrators

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® 2000 Vancomycin Calibrators FDA UDI
Generic Name
Vancomycin therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
Syva® Emit® 2000 Vancomycin Calibrators FDA UDI
Model / Reference
10445337 FDA UDI
Description
Syva® Emit® 2000 Vancomycin Calibrators FDA UDI

Identifiers

Catalog Number
4W109UL FDA UDI
Primary DI / UDI-DI
00842768001116 FDA UDI
510(k) Number
K020845 FDA UDI
FDA Product Code
DLJ FDA UDI
GMDN Term
Vancomycin therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 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: Vancomycin therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Vancomycin Calibrators by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vancomycin therapeutic drug monitoring IVD, calibrator.

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 c2f27315-6f89-4773-a62a-f244cd1d8323 37 fields · synced Jun 8, 2026