Immco Diagnostics

Primary DI
05391516746595
Brand
Immco Diagnostics
Company
CLARK LABORATORIES, INC.
Model
5175
Catalog number
5175
Device description
ImmuLisa™ Enhanced ANA Screen
Published
2019-10-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05391516746595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391516746595053915167465955391516746595

GMDN Terms#

Term, Definition table
TermDefinition
Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) 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
1-800-325-3424customerservice@trinityusa.com

Regulatory Flags#

DUNS number
623214079
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391516743914Trinity Biotech233900023390002016-09-19
05391516742276Trinity Biotech805A805A2017-05-07
05391516743938Trinity Biotech233910023391002016-09-23
05391516746533Trinity Biotech5257002019-12-27
05391516747455Trinity Biotech43842402019-12-31
05391516743822Trinity Biotech233817023381702016-09-22
05391516743860Trinity Biotech233857023385702016-09-22
05391516747172Trinity Biotech233857123385712016-09-22
05391516747202Trinity Biotech234698023469802016-09-19
05391516747387BartelsB1029-90CB1029-90C2017-05-07
05391516747394BartelsB1029-90DB1029-90D2017-05-07
05391516743372Trinity Biotech232510023251002016-09-21
05391516746960Trinity Biotech232510123251012016-09-21
05391516746588Bio-StatYY601262019-12-30
05391516747424Phoenix BiotechTS-96-Bulk2019-12-30
05391516747493Immco230AWI2019-12-30
05391516746519Trinity Biotech8271022019-12-27
05391516746526Trinity Biotech9154012019-12-27
05391516746687Bio-Rad72517725172019-12-27
05391516746854Trinity Biotech8274022019-12-27

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
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
00845714002182IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.LKJ2016-09-23