FDA.reportPublic FDA data

CIC-C1q ELISA Kit

Primary DI
EBUHEKCIC1
Brand
CIC-C1q ELISA Kit
Company
Bühlmann Laboratories AG
Model
EK-CIC
Catalog number
EK-CIC
Device 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.
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DAKComplement C1q, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAKComplement C1q, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012576000CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.2002-01-29DAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBUHEKCIC1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-specific circulating immune complex (CIC) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative non-specific detection of circulating immune complexes (CIC) in a clinical specimen (i.e., no antibody variable region binding and no specific disease/infection identification), using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius28 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 300-9799info@buhlmannlabs.com

Regulatory Flags#

DUNS number
481261006
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426950514190QUANTA Lite® C1q CIC ELISAINOVA DIAGNOSTICS, INC.DAK2026-04-20
B1761110Antiserum to Human C1qKENT LABORATORIES INCDAK2016-09-24
B1761112Anti Human Complement C1q FITCKENT LABORATORIES INCDAK2016-09-24
05051700010511Human Complement C1q BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDAK2016-09-24
00813545023737Scanlisa C1q Elisa 96 Test SCIMEDX CORPORATIONDAK2016-09-20
00813545023744C1q Plates & Calibrator Sets SCIMEDX CORPORATIONDAK2016-09-20
30014613335535MicroVueQUIDEL CORPORATIONDAK2016-09-15
30014613335559MicroVueQUIDEL CORPORATIONDAK2016-09-15