FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817007026
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
230AW
Catalog number
230AW
Device description
Autoimmune EIA Wash Concentrate, 60 mL
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
LKJANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKJAntinuclear Antibody, Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954723000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954723000ENZYME IMMUNOASSAY ANA SCREENING TEST KITHelix Diagnostics, Inc.1995-12-15LKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817007026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817007026008478170070268478170070260847817007026

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume60Milliliter

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
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
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test KitGold Standard Diagnostics CorporationLKJ2025-02-26
07333066015545EliA Ro60 WellPhadia ABLKJ2022-09-14
07333066015576EliA Ro52 WellPhadia ABLKJ2022-09-14
07333066014876EliA Ro60 WellPhadia ABLKJ2022-09-14
07333066014906EliA Ro52 WellPhadia ABLKJ2022-09-14
05391516747493ImmcoCLARK LABORATORIES, INC.LKJ2019-12-30
05391516746595Immco DiagnosticsCLARK LABORATORIES, INC.LKJ2019-10-25
00845714003233Immco DiagnosticsIMMCO DIAGNOSTICS, INC.LKJ2018-06-05
04250289503501AESKULISA® ANA HEp-2 Aesku.Diagnostics GmbH & Co. KGLKJ2017-02-28
00845714003219Immco Diagnostics, Inc.IMMCO DIAGNOSTICS, INC.LKJ2017-02-02
00845714004162IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-12-09
00845714004179IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-12-09
00845714003462IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-10-27
00845714004186IMMCO DIAGNOSTICIMMCO DIAGNOSTICS, INC.LKJ2016-10-27
07333066014524EliA U1RNP WellPhadia ABLKJ2016-09-23
07333066014531EliA Sm WellPhadia ABLKJ2016-09-23
07333066014548EliA Ro WellPhadia ABLKJ2016-09-23
07333066014555EliA La WellPhadia ABLKJ2016-09-23
07333066014562EliA CENP WellPhadia ABLKJ2016-09-23
00840733101014ANA Screen ELISA Test KitMERIDIAN BIOSCIENCE, INC.LKJ2016-09-23
07333066010564EliA U1RNP WellPhadia ABLKJ2016-09-23
07333066010571EliA Sm WellPhadia ABLKJ2016-09-23
07333066010588EliA Ro WellPhadia ABLKJ2016-09-23
07333066010595EliA La WellPhadia ABLKJ2016-09-23
07333066010601EliA CENP WellPhadia ABLKJ2016-09-23
00845714001932IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001949IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001956IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001963IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23
00845714001970IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23