FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817022388
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
96EP
Catalog number
96EP
Device description
Autoimmune EIA ENA Plus Screening test
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLLEXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLLExtractable Antinuclear Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952253000ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KITHelix Diagnostics, Inc.1995-08-24LLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817022388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817022388008478170223888478170223880847817022388

GMDN Terms#

Term, Definition table
TermDefinition
Multiple extractable nuclear antigen (ENA) 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 extractable nuclear antigens (ENA) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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)224-6723TechSupport.USSD@bio-rad.com

Regulatory Flags#

DUNS number
884513334
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894175000725AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.LLL2026-02-27
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LLL2023-12-14
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
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
08426950793182QUANTA Flash® HMGCR ReagentsINOVA DIAGNOSTICS, INC.LLL2018-10-31
08426950595786QUANTA Flash® SS-B ReagentsINOVA DIAGNOSTICS, INC.LLL2017-08-28
04250289502924AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2017-02-28
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LLL2016-10-27
10080196000616MedlineMEDLINE INDUSTRIES, INC.LLL2016-10-14
04250289500449AESKULISA® ENA-6S Aesku.Diagnostics GmbH & Co. KGLLL2016-09-27
00816879020144Autostat II ENA-6 ScreenHYCOR BIOMEDICAL LLCLLL2016-09-26