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Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution

FDA UDI

Class I (US FDA UDI)

by Transene Company, Inc.

Identity

Trade Name
Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution FDA UDI
Generic Name
Multiple respiratory disease-associated bacteria nucleic acid IVD, calibrator FDA UDI
Device Name
Ziehl Neelsen Carbol Fuchsin Solution FDA UDI
Model / Reference
1 FDA UDI
Description
Ziehl Neelsen Carbol Fuchsin Solution FDA UDI

Identifiers

Catalog Number
SO-471 FDA UDI
Primary DI / UDI-DI
SO471852042008 FDA UDI
FDA Product Code
ICL FDA UDI
GMDN Term
Multiple respiratory disease-associated bacteria nucleic acid IVD, calibrator 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

No

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: Multiple respiratory disease-associated bacteria nucleic acid IVD, calibrator

Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin Solution by Transene Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Transene Company, Inc.

Sources (1)

  • FDA UDI 18b7a6bc-1978-459a-abb9-ec6117e04e04 35 fields · synced May 30, 2026