FDA.reportPublic FDA data

Aptiva® CTD Essential Reagent

Primary DI
08430793040051
Brand
Aptiva® CTD Essential Reagent
Company
INOVA DIAGNOSTICS, INC.
Model
723100
Device description
1. Aptiva CTD Essential Reagent Cartridge: a. CTD Essential Beads-Synthetic dsDNA antigen-Native RNP antigen -Sm and Ribosomal-P peptides-Recombinant Ro52, Ro60, SSB, Scl-70, Jo-1, Centromere B and DFS70 antigen -Anti-human IgG antigen (goat) -Bovine protein stabilizerb. Assay buffer-Bovine protein stabilizer -Sodium azidec. PE Tracer IgG-Goat anti-human IgG -Bovine protein stabilizer -Sodium azided. Rehydration buffer Bovine protein stabilizer Sodium azide
Published
2023-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIMTest, Screening, For D Positive Fetal Rbc'S
LKOAnti-Rnp Antibody, Antigen And Control
LKPAnti-Sm Antibody, Antigen And Control
LLLExtractable Antinuclear Antibody, Antigen And Control
LSWAnti-Dna Antibody, Antigen And Control
MQAAnti-Ribosomal P Antibodies
OBEAnti-Ss-A 52 Autoantibodies

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIMTest, Screening, For D Positive Fetal Rbc'SHematology2
LKOAnti-Rnp Antibody, Antigen And ControlImmunology2
LKPAnti-Sm Antibody, Antigen And ControlImmunology2
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2
LSWAnti-Dna Antibody, Antigen And ControlImmunology2
MQAAnti-Ribosomal P AntibodiesImmunology2
OBEAnti-Ss-A 52 AutoantibodiesImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213403000Aptiva CTD Essential ReagentInova Diagnostics, Inc.2023-09-29LLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08430793040051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08430793040051084307930400518430793040051

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a multiplex 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
1-800-678-0710TechSupport.na@werfen.com

Regulatory Flags#

DUNS number
188354831
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
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive Control7040732026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control7040052026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control7040092026-06-09
08430793040761Aptiva® APS IgG Calibrators7251012024-03-11
08426950514190QUANTA Lite® C1q CIC ELISA7046202026-04-20
08430793041140Aptiva® Optical Cleaning SolutionAC10032024-03-11
08426950454373QUANTA Lite® ANA ELISA7087502016-08-31
08426950456193NOVA Lite® HEp-2 ANA Kit7081002016-08-31
08426950593461NOVA Lite® HEp-2 ANA Kit7081012016-08-31
08426950593577NOVA Lite® ANA Kit with DAPI7081022016-08-31
08426950594208NOVA Lite® HEp-2 External EB Kits7042352016-08-31
08426950594857NOVA Lite® Auto AB Panel 7081802016-08-31
08426950595267NOVA Lite® HEp-2 External EB Kits7042302016-08-31
08430793040181Aptiva® CTD Essential Calibrators7231012023-12-14
08430793040198Aptiva® CTD Essential Controls7231022023-12-14
08426950506324NOVA Lite® ANA KSL Kit7083902016-08-31
08426950514008NOVA Lite® ANA KSL Kit7083802016-08-31
08426950514176NOVA Lite®Rat Liver , Kidney, Stomach Kit7041702016-08-31
08426950545798NOVA Lite®Rat Liver , Kidney, Stomach Kit7041802016-08-31
08426950593539NOVA Lite® HEp-2 ANA Plus Mouse Kidney & Stomach7081502016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04048474039016ENA-6-Profile ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-31
04048474027730ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLLL2023-08-29
00840239039019ENA-6-Profile ELISADRG International IncLLL2023-08-25
00840239035714ENA Screen ELISADRG International IncLLL2023-08-24
00840239027733ANA Screen IgG ELISA DRG International IncLLL2023-08-23
B3507202500Gold Standard Diagnostics Is-anti-SS-A ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202600Gold Standard Diagnostics Is-anti-SS-B ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202700Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202900Gold Standard Diagnostics Is-anti-Jo-1 ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-05
B3507202400Gold Standard Diagnostics Is-anti-Sm ELISA Test KitGold Standard Diagnostics CorporationLLL2022-12-03
07333066015538EliA Rib-P WellPhadia ABMQA2021-10-08
07333066014869EliA Rib-P WellPhadia ABMQA2021-10-08
00894175000237AccuDiag ™Diagnostic Automation, Inc.LSW2021-08-06
07333066021485EliA SmDP-S WellPhadia ABLKP2021-07-20
07333066017709EliA SmDP-S WellPhadia ABLKP2021-07-20
B3507202800Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test KitGold Standard Diagnostics CorporationLLL2020-07-27
07333066016115EliA SymphonyS WellPhadia ABLLL2020-06-30
07333066016108EliA SymphonyS WellPhadia ABLLL2020-06-30
05391516746854Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-27
05391516746762Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
05391516746809Trinity BiotechCLARK LABORATORIES, INC.LLL2019-12-26
04048474035711ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
00404847435719ENA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLLL2019-06-10
07333066019406EliA dsDNA WellPhadia ABLSW2019-03-06
07333066010557EliA dsDNA WellPhadia ABLSW2019-03-06
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
04250289510394AESKUSLIDES nDNA (Crithidia luciliae)Aesku.Diagnostics GmbH & Co. KGLSW2018-05-14
08426950595786QUANTA Flash® SS-B ReagentsINOVA DIAGNOSTICS, INC.LLL2017-08-28