FDA.reportPublic FDA data

Alinity

Primary DI
00380740180928
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
08P6802
Catalog number
08P6802
Device description
Alinity c Tox Qual Calibrators
Published
2020-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DKBCalibrators, drug mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740180928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740180928003807401809283807401809280380740180928

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202859Alinity06P016106P01612025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840937114636ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114643ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114650ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114667ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
20613647025295FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
00840937112083ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112090ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112106ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00840937112113ImmunalysisIMMUNALYSIS CORPDKB2021-02-05
00811727016850Pointe Universal Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017550Pointe Multi-Analyte Set C Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017567Pointe Multi-Analyte Set C Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017628Pointe Multi-Analyte Set D Urine DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017642Pointe Multi-Analyte Set D Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017727Pointe Multi-Analyte E DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00380740179342AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179359AlinityABBOTT LABORATORIESDKB2020-05-11
00380740179366AlinityABBOTT LABORATORIESDKB2020-05-11
00840937111895ImmunalysisIMMUNALYSIS CORPDKB2020-03-31
00840937111918ImmunalysisIMMUNALYSIS CORPDKB2020-03-31