FDA.reportPublic FDA data

MeDiCa

Primary DI
00813545026936
Brand
MeDiCa
Company
SCIMEDX CORPORATION
Model
2001-96
Catalog number
2001-96
Device description
A-nDNA-A Crithidia luciliae 96 Test Kit
Published
2020-11-04
Public version status
New
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
DHCSystem, Test, Systemic Lupus Erythematosus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHCSystem, Test, Systemic Lupus ErythematosusImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790106000IIF-A-N-DNA TEST KITMedica Corp.1979-03-15DHC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545026936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545026936008135450269368135450269360813545026936

GMDN Terms#

Term, Definition table
TermDefinition
Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to native DNA (anti-nDNA) in a clinical specimen, using a fluorescent immunoassay 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
00850049545907AccuDiag ™Diagnostic Automation, Inc.DHC2023-06-14
00813545026585MeDiCaSCIMEDX CORPORATIONDHC2020-12-01
00813545026592MeDiCaSCIMEDX CORPORATIONDHC2020-12-01
00813545026929MeDiCaSCIMEDX CORPORATIONDHC2020-11-04
00813545026943MeDiCaSCIMEDX CORPORATIONDHC2020-11-04
10722355001712Detector Lex SLEImmunostics Company, IncDHC2016-09-21
10722355001729Detector Lex SLEImmunostics Company, IncDHC2016-09-21
00847817018206Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018213Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018220Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018237Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018244Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018251Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018268Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018275Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
00847817018282Autoimmune EIABIO-RAD LABORATORIES, INC.DHC2016-09-12
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00855360006137Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well)CORGENIX MEDICAL CORPORATIONDHC2016-07-14
00855360006212REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit CORGENIX MEDICAL CORPORATIONDHC2016-07-14
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00816057020225ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020232ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020249ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
00816057020256ASI SLE Slide TestARLINGTON SCIENTIFIC, INC.DHC2016-07-08
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