FDA.reportPublic FDA data

C3d Plates & Calibrator Sets

Primary DI
00813545023836
Brand
C3d Plates & Calibrator Sets
Company
SCIMEDX CORPORATION
Model
C3DCP
Catalog number
C3DCP
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
CZWComplement C3, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CZWComplement C3, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861362000IMMUNOMEDICS SERUM ELISA TEST SYSTEMImmunomedics, Inc.1986-06-06CZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545023836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545023836008135450238368135450238360813545023836

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C3/C3c IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of complement cascade components C3 and/or C3c 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
00380740170172AlinityABBOTT IRELANDCZW2021-05-13
00380740170189ARCHITECTABBOTT IRELANDCZW2021-03-26
00380740175153ARCHITECTAbbott GmbHCZW2020-11-06
07613336133590Tina-quant Complement C3c Ver.2Roche Diagnostics GmbHCZW2020-03-05
00380740150662AlinityAbbott GmbHCZW2019-06-27
00630414595665Atellica CH C3Siemens Healthcare Diagnostics Inc.CZW2017-12-27
15099590010560AUBeckman Coulter, Inc.CZW2016-09-24
B1761050Antiserum to Human C-3 (b1c/b1a)KENT LABORATORIES INCCZW2016-09-24
B1761052Anti Human C-3 (b1c/b1a) FITCKENT LABORATORIES INCCZW2016-09-24
B1761190Antiserum to Human C-3 (b1c)KENT LABORATORIES INCCZW2016-09-24
05051700010542Human Complement C3 ‘NL’ BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700015578Human C3c Kit for use on the SPAplusTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
05051700017596Optilite C3c KitTHE BINDING SITE GROUP LIMITEDCZW2016-09-24
00842768005220Dimension® Flex® reagent cartridge C3Siemens Healthcare Diagnostics Inc.CZW2016-09-24
00842768006050Dimension Vista® C3 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009716N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00842768009723N Antiserum to Human C3cSiemens Healthcare Diagnostics Products GmbHCZW2016-09-24
00630414517735ADVIA® Chemistry C3 Complement C3 ReagentsSiemens Healthcare Diagnostics Inc.CZW2016-09-24
04015630910274Tinaquant C3cRoche Diagnostics GmbHCZW2016-09-20
04015630917709Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
04015630928422Tinaquant Complement C3c ver2Roche Diagnostics GmbHCZW2016-09-20
00813545023829Scanlisa C3d Elisa 96 Test SCIMEDX CORPORATIONCZW2016-09-20
05055273201611C3RANDOX LABORATORIES LIMITEDCZW2016-09-16
05700572002482Poly Rb A-Hu C3c Complement/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZW2016-09-16
00816426020078K-ASSAY® Complement C3 ReagentKAMIYA BIOMEDICAL COMPANY, LLCCZW2016-09-16
00817302020922CAROLINA LIQUID CHEMISTRIES CORP.® C3 Complement C3 CC634CAROLINA LIQUID CHEMISTRIES CORPORATIONCZW2016-09-01
15099590229733SynchronBeckman Coulter, Inc.CZW2016-08-24
15099590230487IMMAGEBeckman Coulter, Inc.CZW2016-08-24
10758750006847VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CZW2016-08-23