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Syva® Emit® LSD 2.5 ng/mL Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Syva® Emit® LSD 2.5 ng/mL Calibrator FDA UDI
Generic Name
Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator FDA UDI
Device Name
Syva® Emit® LSD 2.5 ng/mL Calibrator FDA UDI
Model / Reference
10445458 FDA UDI
Description
Syva® Emit® LSD 2.5 ng/mL Calibrator FDA UDI

Identifiers

Catalog Number
9L309UL FDA UDI
Primary DI / UDI-DI
00842768002083 FDA UDI
510(k) Number
K955448 FDA UDI
FDA Product Code
DLB FDA UDI
GMDN Term
Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3580 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: Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator

Syva® Emit® LSD 2.5 ng/mL Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lysergic acid diethylamide (LSD)/LSD metabolite IVD, calibrator.

Cleared under the same submission

K955448 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 5942b169-3a14-4043-895f-14438c6d1653 37 fields · synced Jun 8, 2026