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IgM Component Pack - Bulk

FDA UDI

Class I (US FDA UDI)

by Gold Standard Diagnostics, LLC

Identity

Trade Name
IgM Component Pack - Bulk FDA UDI
Generic Name
Enzyme immunoassay (EIA) generic reagent kit IVD FDA UDI
Device Name
IgM Component Pack - Bulk FDA UDI
Model / Reference
GSD05-1701-CP FDA UDI
Description
IgM Component Pack - Bulk FDA UDI

Identifiers

Catalog Number
GSD05-1701-CP FDA UDI
Primary DI / UDI-DI
B350GSD051701CP0 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Enzyme immunoassay (EIA) generic reagent kit IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Enzyme immunoassay (EIA) generic reagent kit IVD

IgM Component Pack - Bulk by Gold Standard Diagnostics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Enzyme immunoassay (EIA) generic reagent kit IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gold Standard Diagnostics, LLC

Sources (1)

  • FDA UDI cb608ae6-55f8-44d6-8dbe-ddc1f87880d6 35 fields · synced Jun 8, 2026