FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817022463
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
96SS
Catalog number
96SS
Device description
Autoimmune EIA Anti-ssDNA 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
LRMANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001900000ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTHelix Diagnostics, Inc.2000-09-11LRM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817022463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817022463008478170224638478170224630847817022463

GMDN Terms#

Term, Definition table
TermDefinition
Single stranded DNA antibody (anti-ssDNA) 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 antibodies to single stranded DNA (anti-ssDNA) 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
00840239034380Anti-dsDNA IgG ELISADRG International IncLRM2023-08-24
00840239035646Anti-dsDNA IgM ELISADRG International IncLRM2023-08-24
00840239035653Anti-dsDNA IgA ELISADRG International IncLRM2023-08-24
00840239035660Anti-dsDNA Screen ELISADRG International IncLRM2023-08-24
B3507207000Gold Standard Diagnostics Is-anti-dsDNA ELISA Test KitGold Standard Diagnostics CorporationLRM2022-12-02
04048474034387Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035643Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035650Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
04048474035667Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847434385Anti-dsDNA IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435641Anti-dsDNA IgM ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435658Anti-dsDNA IgA ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00404847435665Anti-dsDNA Screen ELISADRG Instruments Gesellschaft mit beschränkter HaftungLRM2019-06-10
00845714002786IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002922IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714004247IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-12-09
00845714002960IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-10-27
00816879020014Autostat II Anti-ds-DNAHYCOR BIOMEDICAL LLCLRM2016-09-26
04049016026884Anti-dsDNA-NcX ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLRM2016-09-24
05391516743723Trinity BiotechCLARK LABORATORIES, INC.LRM2016-09-22
00845714001888IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LRM2016-09-21
00817273020372DiamedixDIAMEDIX CORPORATIONLRM2016-09-20
05391516747141Trinity BiotechCLARK LABORATORIES, INC.LRM2016-09-19
00847817006937Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817007033Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817007040Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847817022364Autoimmune EIABIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000086BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865000093BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12
00847865001342BioPlex 2200BIO-RAD LABORATORIES, INC.LRM2016-09-12