FDA.reportPublic FDA data

ENA-6Pro ELISA

Primary DI
B24235E6PHUE010
Brand
ENA-6Pro ELISA
Company
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
Model
35-E6PHU-E01
Catalog number
35-E6PHU-E01
Device description
The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings.
Published
2017-08-28
Public version status
Update
Distribution status
Not 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
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, ControlsImmunology2

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
B24235E6PHUE010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen auto-antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple auto-antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen, using an enzyme immunoassay (EIA) 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
800.592.5726cs@alpco.com

Regulatory Flags#

DUNS number
784143778
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048474027877Jo-1 IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
04048474035803Anti-Scl-70 ELISADRG Instruments Gesellschaft mit beschränkter HaftungLJM2023-08-29
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