FDA.reportPublic FDA data

DIASTAT anti-Ro (SS-A)

Primary DI
07340058410004
Brand
DIASTAT anti-Ro (SS-A)
Company
Svar Life Science AB
Model
FARO300
Catalog number
FARO300
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LKOAnti-Rnp Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905194000DIASTAT ANTI-RO (SS-A)Shield Diagnostics, Ltd.1990-12-13LKO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07340058410004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07340058410004073400584100047340058410004

GMDN Terms#

Term, Definition table
TermDefinition
SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
559894501
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
07340058410011DIASTAT anti-La (SS-B)FALA200FALA2002016-08-12
07340058410028DIASTAT anti-Sm/RNPFRNP200FRNP2002016-08-12
07340058410035DIASTAT anti-dsDNAFDNA100FDNA1002016-08-12
07340058410059DIASTST anti-SmFASM200FASM2002016-08-12
07340058410110DIASTAT anti-thyroglobulinFATG200FATG2002016-08-12
07340058410134DIASTAT anti-Thyroid PeroxidaseFTPO300FTPO3002016-08-08
07340058410141DIASTAT anti-B2 Glycoprotein-1 IgGFBGP200FBGP2002016-08-12
07340058410158DIASTAT anti-B2-Glycoprotein-1 IgMFBGP100FBGP1002016-08-12
07340058410196DIASTAT anti-Cardiolipin IgGFCAR100GFCAR100G2016-08-12
07340058410233DIASTAT anti-Cardiolipin IgMFCAR100MFCAR100M2016-08-12
07340058410400DIASTAT total anti-CardiolipinFCAR100TFCAR100T2016-08-12
07340058410417DIASTAT anti-MitochondrialFMIT200FMIT2002016-08-12
07340058410431CCPointCCPoint20USCCPoint20US2016-09-09
07340058410462DIASTAT anti-SCL-70FSCL200FSCL2002016-08-12
07340058410479DIASTAT anti-Jo-1FAJO200FAJO2002016-08-12
07340058410486DIASTAT ANAFANA200FANA2002016-08-12
07340058410493DIASTAT ENA Single Well ScreenFSWS200FSWS2002016-08-12
07340058410509DIASTAT ENA ProfileFAID200FAID2002016-08-12
07340058410615EDIA anti-CCPFCCP100FCCP1002016-08-12
07340058410639WIESLAB ANCA Screen kitCP111CP1112016-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKO2023-12-14
00816879020328Autostat II Anti-Sm/RNPHYCOR BIOMEDICAL LLCLKO2016-09-26
04049016027010Anti-nRNP/Sm ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKO2016-09-24
07333066014623EliA RNP70 WellPhadia ABLKO2016-09-23
07333066010663EliA RNP70 WellPhadia ABLKO2016-09-23
00847817022456Autoimmune EIABIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865002448BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865002721BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
00847865012331BioPlex 2200BIO-RAD LABORATORIES, INC.LKO2016-09-12
08426950595151QUANTA Flash® RNP ReagentsINOVA DIAGNOSTICS, INC.LKO2016-08-31
07340058410011DIASTAT anti-La (SS-B)Svar Life Science ABLKO2016-08-12