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Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells

FDA UDI

Class I (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells FDA UDI
Generic Name
Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
1525-300 FDA UDI

Identifiers

Catalog Number
1525-300A FDA UDI
Primary DI / UDI-DI
00816870021096 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 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

Yes

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 — 7.75 Inch FDA UDI

Category: Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Anti-H. Pylori IgG AccuBind ELISA Test System - 96 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helicobacter pylori immunoglobulin M (IgM) antibody 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 c6574762-403a-47ee-8bd7-19c575a99b05 36 fields · synced May 30, 2026