← Back to catalogue

Microtiterplates (5)

FDA UDI

Class II (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
Microtiterplates (5) FDA UDI
Generic Name
Assay container IVD, single-use FDA UDI
Device Name
Microtiterplates (5) FDA UDI
Model / Reference
GSD05-1600-MW FDA UDI
Description
Microtiterplates (5) FDA UDI

Identifiers

Catalog Number
GSD05-1600-MW FDA UDI
Primary DI / UDI-DI
B350GSD051600MW0 FDA UDI
510(k) Number
K150358 FDA UDI
FDA Product Code
GMQ FDA UDI
GMDN Term
Assay container IVD, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Assay container IVD, single-useTreponema pallidum reagin antibody IVD, kit, agglutination

Microtiterplates (5) by Gold Standard Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Treponema pallidum reagin antibody IVD, kit, agglutination.

Cleared under the same submission

K150358 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
Gold Standard Diagnostics, LLC

Sources (1)

  • FDA UDI 1f34f1fe-a73f-4b17-a105-78f407c960cd 35 fields · synced Jun 8, 2026