FDA.reportPublic FDA data

Liquichek

Primary DI
00847661000167
Brand
Liquichek
Company
BIO-RAD LABORATORIES, INC.
Model
116
Catalog number
116
Device description
Liquichek Anti-RNP Control, Positive (A pre-diluted human serum autoimmune control.)
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
K024223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024223000LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116Bio-Rad2003-01-13LKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847661000167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847661000167008476610001678476610001670847661000167

GMDN Terms#

Term, Definition table
TermDefinition
Sm/RNP antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to Sm/RNP antigen complex (anti-Sm/RNP) in a clinical specimen.

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)854-6737qsd.techservice@bio-rad.com

Regulatory Flags#

DUNS number
051624070
Device count
1
Lot or batch
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