← Back to catalogue

Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells

FDA UDI

Class I (US FDA UDI)

by Monobind, Inc.

Identity

Trade Name
Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 96 Wells FDA UDI
Generic Name
Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference
1475-300 FDA UDI

Identifiers

Catalog Number
1475-300A FDA UDI
Primary DI / UDI-DI
00816870022741 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

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

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 7.75 Inch FDA UDI

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

Monobind AccuLite Anti-H. Pylori IgM CLIA Kit - 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA UDI dc724f1d-ca35-4a6a-8c8e-6054a8242d5a 36 fields · synced Jun 8, 2026