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Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name
Henry Schein FDA UDI
Generic Name
Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI
Device Name
Maxicide OPA 28 Test Strips FDA UDI
Model / Reference
1126977 FDA UDI
Description
Maxicide OPA 28 Test Strips FDA UDI

Identifiers

Catalog Number
1126977 FDA UDI
Primary DI / UDI-DI
00304040005194 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Ortho-phthalaldehyde (OPA) device disinfectant test strip FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ortho-phthalaldehyde (OPA) device disinfectant test strip

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ortho-phthalaldehyde (OPA) device disinfectant test strip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA UDI 8720a45f-df25-4b3e-be08-9a56c5610c68 34 fields · synced Jun 8, 2026