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CIC-C1q ELISA Kit

FDA UDI

Class II (US FDA UDI)

by Bühlmann Laboratories AG

Identity

Trade Name
CIC-C1q ELISA Kit FDA UDI
Generic Name
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
The BÜHLMANN CIC-C1Q EIA is intended for the quantitative in vitro diagnostic determination of circulating immune complexes (CIC) in serum and plasma of patients with various autoimmune and other CIC-related diseases. FDA UDI
Model / Reference
EK-CIC FDA UDI
Description
The BÜHLMANN CIC-C1Q EIA is intended for the quantitative in vitro diagnostic determination of circulating immune complexes (CIC) in serum and plasma of patients with various autoimmune and other CIC-related diseases. FDA UDI

Identifiers

Catalog Number
EK-CIC FDA UDI
Primary DI / UDI-DI
EBUHEKCIC1 FDA UDI
510(k) Number
K012576 FDA UDI
FDA Product Code
DAK FDA UDI
GMDN Term
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)

CIC-C1q ELISA Kit by Bühlmann Laboratories AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bühlmann Laboratories AG

Sources (1)

  • FDA UDI c30b16c6-93ef-4c36-b7c7-7c817fb8ef97 37 fields · synced May 30, 2026