FDA.reportPublic FDA data

Autoimmune EIA

Primary DI
00847817022449
Brand
Autoimmune EIA
Company
BIO-RAD LABORATORIES, INC.
Model
96SM
Catalog number
96SM
Device description
Autoimmune EIA Anti-Sm 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
LKPANTI-SM ANTIBODY, ANTIGEN AND CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKPAnti-Sm Antibody, Antigen And ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K940510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K940510000ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KITHelix Diagnostics, Inc.1994-04-20LKP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817022449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817022449008478170224498478170224490847817022449

GMDN Terms#

Term, Definition table
TermDefinition
Smith antibody (anti-Sm) 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 anti-Smith (anti-Sm) antibodies 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
08430793040051Aptiva® CTD Essential ReagentINOVA DIAGNOSTICS, INC.LKP2023-12-14
07333066021485EliA SmDP-S WellPhadia ABLKP2021-07-20
07333066017709EliA SmDP-S WellPhadia ABLKP2021-07-20
00816879020311Autostat II Anti-SmHYCOR BIOMEDICAL LLCLKP2016-09-26
04049016027027Anti-Sm ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016083139EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016084785EUROLINE ENA ProfilePlus 4 (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124900EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
04049016124917EUROLINE ENA Profile 9 Ag (IgG)EUROIMMUN Medizinische Labordiagnostika AGLKP2016-09-24
07333066014838EliA SmDP WellPhadia ABLKP2016-09-23
07333066010885EliA SmDP WellPhadia ABLKP2016-09-23
00847661000150LiquichekBIO-RAD LABORATORIES, INC.LKP2016-09-12
08426950595533QUANTA Flash® Sm ReagentsINOVA DIAGNOSTICS, INC.LKP2016-08-31
00850487007050ReQuest QUEST INTERNATIONAL, INC.LKP2016-08-31
00850487007265ReQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
00850487007593SeraQuestQUEST INTERNATIONAL, INC.LKP2016-08-31
07340058410028DIASTAT anti-Sm/RNPSvar Life Science ABLKP2016-08-12
07340058410059DIASTST anti-SmSvar Life Science ABLKP2016-08-12