Camco

FDA UDI

Class I (US FDA UDI)

by Cambridge Diagnostic Products, Inc.

Identity

Trade Name: Camco FDA UDI
Generic Name: Romanowsky stain IVD, kit FDA UDI
Device Name: Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity color projection and electrolytes for sharper contrast. FDA UDI
Model / Reference: 2000 FDA UDI
Description: Camco Poly-Tet stain - Wright stain with blue-red coloration with high intensity color projection and electrolytes for sharper contrast. FDA UDI

Identifiers

Catalog Number: 2000 FDA UDI
Primary DI / UDI-DI: 00691573200005 FDA UDI
FDA Product Code: KQC FDA UDI
GMDN Term: Romanowsky stain 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

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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 1 Quart FDA UDI

Category: Romanowsky stain IVD, kit

Camco by Cambridge Diagnostic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Cambridge Diagnostic Products, Inc.

Sources (1)

FDA UDI 8fa9e9f9-8c44-4209-ab19-60f76ac03005 37 fields · synced Jun 1, 2026