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IgE AccuBind ELISA Test System - 480 Wells

FDA UDI

Class II (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
IgE AccuBind ELISA Test System - 480 Wells FDA UDI
Generic Name
Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
2525-300 FDA UDI

Identifiers

Catalog Number
2525-300D FDA UDI
Primary DI / UDI-DI
00816870020266 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 12 Inch FDA UDI

Category: Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)

IgE AccuBind ELISA Test System - 480 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA UDI 223973a4-328c-4278-9b83-929c0a64be20 36 fields · synced May 30, 2026