FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817018534
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
425-2320
Catalog number
4252320
Device description
Autoimmune EIA Anti-Saccharomyces Cerevisiae Antibodies (ASCA) IgA
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
NBTANTIBODIES,SACCHAROMYCES CEREVISIAE (S.CEREVISIAE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051492000AESKULISA ASCA AAesku, Inc.2005-11-14NBT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817018534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817018534008478170185348478170185340847817018534

GMDN Terms#

Term, Definition table
TermDefinition
Saccharomyces cerevisiae immunoglobulin A (IgA) antibody IVD, kit enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA) antibodies to the yeast Saccharomyces cerevisiae 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
04250289503143AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289503150AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-03-17
04250289502894AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289502900AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2017-02-28
04250289501521AESKULISA® ASCA-A Aesku.Diagnostics GmbH & Co. KGNBT2016-09-27
04250289501538AESKULISA® ASCA-G Aesku.Diagnostics GmbH & Co. KGNBT2016-09-27
00847817018541Autoimmune EIABIO-RAD LABORATORIES, INC.NBT2016-09-12
08426950514206QUANTA Lite® ASCA IgG ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31
08426950514213QUANTA Lite® ASCA IgA ELISAINOVA DIAGNOSTICS, INC.NBT2016-08-31
00857031002325ASCA-CHEKTECHLAB, INC.NBT2016-08-20