Rowley Biochemical Hydrochloric Acid 0.25%

FDA UDI

Class I (US FDA UDI)

by Transene Company, Inc.

Identity

Trade Name: Rowley Biochemical Hydrochloric Acid 0.25% FDA UDI
Generic Name: Decalcifying solution IVD FDA UDI
Device Name: Hydrochloric Acid for Papanicolau Staining FDA UDI
Model / Reference: 1 FDA UDI
Description: Hydrochloric Acid for Papanicolau Staining FDA UDI

Identifiers

Primary DI / UDI-DI: M8002852042008 FDA UDI
FDA Product Code: HZJ FDA UDI
GMDN Term: Decalcifying solution IVD 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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: Decalcifying solution IVD

Rowley Biochemical Hydrochloric Acid 0.25% by Transene Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Decalcifying solution IVD.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Transene Company, Inc.

Sources (1)

FDA UDI 63329cb0-b12d-4bc2-a533-b540db8be4a6 34 fields · synced May 30, 2026