CEDIA Negative Calibrator

FDA UDIEUDAMED

Class II (US FDA UDI)

by Microgenics Corporation

Identity

Trade Name: CEDIA Negative Calibrator FDA UDI
Generic Name: Multiple drugs of abuse IVD, calibrator FDA UDI
Model / Reference: 1661388 FDA UDI

Identifiers

Primary DI / UDI-DI: 00884883001961 FDA UDI
FDA Product Code: DKB FDA UDI
GMDN Term: Multiple drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Category: Multiple drugs of abuse IVD, calibrator

CEDIA Negative Calibrator by Microgenics Corporation — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Microgenics Corporation

Sources (2)

FDA UDI 9aa2e38c-686f-4b90-8982-8a00b6364c80 32 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 3, 2026