FDA.reportPublic FDA data

AESKULISA® snRNP-C

Primary DI
04250289502955
Brand
AESKULISA® snRNP-C
Company
Aesku.Diagnostics GmbH & Co. KG
Model
7105US
Catalog number
7105US
Device description
AESKULISA® snRNP-C is a solid phase enzyme immunoassay for the qualitative and semiquantitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex purified from the cell-line HeLa. The U1-snRNP complex comprises of the Smith antigen (Sm) and RNPs, the 70 kDa U1-specific protein plus protein A and C. The assay is an aid for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) and should be used in conjunction with other serological tests and clinical findings.
Published
2017-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
LLLExtractable Antinuclear Antibody, Antigen And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032469000AESKULISA ANA 8PROAesku, Inc.2003-12-16LLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250289502955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250289502955042502895029554250289502955

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
341714388
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
04250289503020AESKULISA® ANA-HEp-27115US7115US2017-03-02
04250289503037AESKULISA® dsDNA-G7142US7142US2017-03-17
04250289503099AESKULISA® ß2-Glyco-Check7215US7215US2017-02-28
04250289503143AESKULISA® ASCA-A7507US7507US2017-03-17
04250289503150AESKULISA® ASCA-G7508US7508US2017-03-17
04250289502849AESKULISA® ß2-Glyco-Check30-7215US30-7215US2017-02-28
04250289502894AESKULISA® ASCA-A30-7507US30-7507US2017-02-28
04250289502979AESKULISA® SS-A7107US7107US2017-02-28
04250289503006AESKULISA® Cenp-B7112US7112US2017-02-28
04250289504584AESKULISA® DGP-A30-7513US30-7513US2017-02-28
04250289500470AESKULISA® snRNP-C31052016-09-27
04250289500494AESKULISA® SS-A31072016-09-27
04250289500548AESKULISA® Cenp-B31122016-09-27
04250289500838AESKULISA® Cardiolipin-A32032016-09-27
04250289500852AESKULISA® ß2-Glyco-A32052016-09-27
04250289500951AESKULISA® ß2-Glyco-Check32152016-09-27
04250289501491AESKULISA® Glia-G35022016-09-27
04250289501521AESKULISA® ASCA-A35072016-09-27
04250289501538AESKULISA® ASCA-G35082016-09-27
04250289503051AESKULISA® Cardiolipin-A7203US7203US2017-02-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
00850054026569QMedix™Diagnostic Automation, Inc.LJM2024-04-23
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
00840239035769Anti-SS-B ELISADRG International IncLJM2023-10-09
04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474041170ANA Detect ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
04048474027747DNA (ds) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027792ENA Screen (entractable nuclear antigen) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027808ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027822SSA (Ro) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027839SSB (La) IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027846Sm IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027853Sm RNP IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027860Scl-70 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474027877Jo-1 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474035803Anti-Scl-70 ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
00084023903579Anti-SS-B ELISA DRG International IncLJM2023-08-25
00840239035776Anti-Sm ELISADRG International IncLJM2023-08-25
00840239035783Anti-RNP/Sm ELISA DRG International IncLJM2023-08-25
00840239035806Anti-Scl-70 ELISADRG International IncLJM2023-08-25
00840239035813Anti-Jo-1 ELISADRG International IncLJM2023-08-25
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239041173ANA Detect ELISADRG International IncLJM2023-08-25
00840239027870Jo-1 IgG ELISADRG International IncLJM2023-08-24
00840239035622ANA-8-Screen ELISADRG International IncLJM2023-08-24
00840239035639ANA-8-Profile ELISADRG International IncLJM2023-08-24
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239035738Anti-SS-A (Ro) ELISADRG International IncLJM2023-08-24