FDA.reportPublic FDA data

EliA dsDNA Well

Primary DI
07333066010557
Brand
EliA dsDNA Well
Company
Phadia AB
Model
DECC055000
Catalog number
DECC055000
Device description
EliA dsDNA Well
Published
2019-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSWANTI-DNA ANTIBODY, ANTIGEN AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSWAnti-Dna Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072393000ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.2007-12-07LSW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07333066010557PackageGS14In Commercial Distribution
07333066019406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07333066010557073330660105577333066010557
07333066019406073330660194067333066019406

GMDN Terms#

Term, Definition table
TermDefinition
Double stranded DNA antibody (anti-dsDNA) 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 double stranded DNA (anti-dsDNA) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+469999999999xx@xx.xx

Regulatory Flags#

DUNS number
354019424
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07333066021812EliA Stool Extraction Kit plus14-6665-0114-6665-012026-06-25
07333066021829EliA Stool Extraction Buffer plus83-1187-0183-1187-012026-06-25
07333066014524EliA U1RNP WellDECC055010DECC0550102016-09-23
07333066014562EliA CENP WellDECC055050DECC0550502016-09-23
07333066014623EliA RNP70 WellDECC055110DECC0551102016-09-23
07333066014630EliA GBM WellDECC055140DECC0551402016-09-23
07333066014678EliA Celikey IgG WellDECC055180DECC0551802016-09-23
07333066014715EliA Cardiolipin IgA WellDECC055280DECC0552802016-09-23
07333066014746EliA ß2-Glycoprotein I IgA WellDECC055310DECC0553102016-09-23
07333066014777EliA PR3S WellDECC055360DECC0553602016-09-23
07333066014784EliA MPOS WellDECC055370DECC0553702016-09-23
07333066014791EliA GliadinDP IgA WellDECC055380DECC0553802016-09-23
07333066014807EliA GliadinDP IgG WellDECC055390DECC0553902016-09-23
07333066014814EliA RF IgM WellDECC056000DECC0560002016-09-23
07333066014852EliA M2 WellDECC056490DECC0564902016-09-23
07333066014593EliA Symphony WellDECC055080DECC0550802016-09-23
07333066016115EliA SymphonyS WellDECC056710DECC0567102020-06-30
07333066015798EliA CCP WellDECC066150DECC0661502026-01-29
07333066024202EliA IgG Calibrator WellDECC066090DECC0660902026-01-29
07333066024226EliA Dummy WellDECC066100DECC0661002026-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250289513401AESKUSLIDES® nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2024-11-15
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LSW2023-12-14
00894175000237AccuDiag ™Diagnostic Automation, Inc.LSW2021-08-06
07333066019406EliA dsDNA WellPhadia ABLSW2019-03-06
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2018-05-14
04250289503037AESKULISA® dsDNA-GAesku.Diagnostics GmbH & Co. KGLSW2017-03-17
04250289503440AESKULISA® dsDNA GAesku.Diagnostics GmbH & Co. KGLSW2017-02-28
B24235DSGHUE010Anti-ds-DNA-G ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.LSW2017-01-18
08426950624646QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31
08426950627760QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.LSW2016-08-31