Dade Ci-Trol Coagulation Control Level 1

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: Dade Ci-Trol Coagulation Control Level 1 FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Device Name: For use as control in citrated coagulation systems FDA UDI
Model / Reference: 10873842 FDA UDI
Description: For use as control in citrated coagulation systems FDA UDI

Identifiers

Catalog Number: 10873842 FDA UDI
Primary DI / UDI-DI: 00630414640167 FDA UDI
FDA Product Code: GGC FDA UDI
GMDN Term: Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 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

Category: Multiple coagulation factor IVD, control

Dade Ci-Trol Coagulation Control Level 1 by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID

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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 II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI f37d87dc-9243-4a2a-8762-1276349bdaec 36 fields · synced Jun 8, 2026