← Back to catalogue

Rowley Biochemical Harris Hematoxylin

FDA UDI

Class I (US FDA UDI)

by Transene Company, Inc.

Identity

Trade Name
Rowley Biochemical Harris Hematoxylin FDA UDI
Generic Name
Haematoxylin and eosin (H&E) stain control IVD, kit FDA UDI
Device Name
Harris Hematoxylin without Mercury FDA UDI
Model / Reference
1 FDA UDI
Description
Harris Hematoxylin without Mercury FDA UDI

Identifiers

Primary DI / UDI-DI
SO942852042008 FDA UDI
FDA Product Code
HZJ FDA UDI
GMDN Term
Haematoxylin and eosin (H&E) stain control IVD, kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.1850 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
Total Volume — 1 Gallon FDA UDI
Total Volume — 1 Quart FDA UDI
Total Volume — 1 Pint FDA UDI
Total Volume — 8 Fluid Ounce FDA UDI
Total Volume — 4 Fluid Ounce FDA UDI

Category: Haematoxylin and eosin (H&E) stain control IVD, kit

Rowley Biochemical Harris Hematoxylin by Transene Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematoxylin and eosin (H&E) stain control IVD, kit.

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
Transene Company, Inc.

Sources (1)

  • FDA UDI 0eab99c8-c989-4567-af90-6d4289085cea 34 fields · synced Jun 8, 2026