FDA.reportPublic FDA data

Scanlisa C1q Elisa 96 Test

Primary DI
00813545023737
Brand
Scanlisa C1q Elisa 96 Test
Company
SCIMEDX CORPORATION
Model
C1196
Catalog number
C1196
Published
2016-09-20
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
K833636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833636000ORTHO* SERUM ELISA TEST SYSTEMOrtho Diagnostic Systems, Inc.1984-06-13DAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545023737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545023737008135450237378135450237370813545023737

GMDN Terms#

Term, Definition table
TermDefinition
Complement component C1q IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade component C1q in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026776MeDiCa082108212020-12-01
00813545026783MeDiCa082208222020-12-01
00813545026790MeDiCa0821-M0821-M2020-12-01
00813545026806MeDiCa0822-M0822-M2020-12-01
00813545026813MeDiCa083108312020-12-01
00813545026820MeDiCa083208322020-12-01
00813545026837MeDiCa0831-M0831-M2020-12-01
00813545026844MeDiCa0832-M0832-M2020-12-01
00813545026851MeDiCa083308332020-12-01
00813545026868MeDiCa0833-M0833-M2020-12-01
00813545026875MeDiCa083408342020-12-01
00813545026882MeDiCa0834-M0834-M2020-12-01
00813545026899MeDiCa0842-RM0842-M2020-12-01
00813545027223MeDiCa8021-488021-482020-12-01
00813545027261MeDiCa8021-4008021-4002020-12-01
00813545027278MeDiCa8021-96-GI8021-96-GI2020-12-01

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
00813545023744C1q Plates & Calibrator Sets SCIMEDX CORPORATIONDAK2016-09-20
30014613335535MicroVueQUIDEL CORPORATIONDAK2016-09-15
30014613335559MicroVueQUIDEL CORPORATIONDAK2016-09-15
EBUHEKCIC1CIC-C1q ELISA KitBühlmann Laboratories AGDAK2016-09-01