FDA.reportPublic FDA data

MassTrak

Primary DI
00816776020438
Brand
MassTrak
Company
WATERS TECHNOLOGIES CORPORATION
Model
186009312IVD
Catalog number
186009312IVD
Device description
MassTrak™ Endocrine Steroid Quality Control Set
Published
2021-10-25
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
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816776020438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020438008167760204388167760204380816776020438

GMDN Terms#

Term, Definition table
TermDefinition
Multiple steroid hormone 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 one or multiple steroid hormones in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002524752customerservice@waters.com

Regulatory Flags#

DUNS number
107186004
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816776020551MassTrak186010565IVD186010564IVD2023-12-05
00816776020247MassTrak186010560IVD186010560IVD2022-12-22
00816776020544MassTrak186010563IVD186010563IVD2023-12-05
00816776020568MassTrak186010565IVD186010565IVD2023-12-05
00816776020575MassTrak186010566IVD186010566IVD2023-12-05
00816776020582MassTrak186010568IVD186010568IVD2023-12-05
00816776020599MassTrak186010567IVD186010567IVD2023-12-05
00816776020254Xevo186009782IVD186009782IVD2023-04-06
00816776020421MassTrak186009311IVD186009311IVD2021-10-25
00816776020445Acquity186015082IVD186015082IVD2022-03-01
00816776020452Acquity186015088IVD186015088IVD2022-03-01
00816776020469Acquity186015087IVD186015087IVD2022-03-01
00816776020476Acquity186015014IVD186015014IVD2022-03-01
00816776020315Acquity725000662IVD725000662IVD2021-10-06
00816776020346Xevo186008453IVD186008453IVD2021-10-06
00816776020179Xevo186007833IVD186007833IVD2021-10-05
00816776020087Acquity186015007IVD186015007IVD2021-10-04
00816776020094Acquity186015010IVD186015010IVD2021-10-04
00816776020100Acquity186015020IVD186015020IVD2021-10-04
00816776020117Acquity186015043IVD186015043IVD2021-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442848Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442855Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
00884883009080MAS Immunology Advanced Sample PackMicrogenics CorporationJJY2026-05-27
00884883011373MAS Immunology Advanced Level 1Microgenics CorporationJJY2026-05-27
00884883011380MAS Immunology Advanced Level 2Microgenics CorporationJJY2026-05-27
00884883011397MAS Immunology Advanced Level 3Microgenics CorporationJJY2026-05-27
00884883011427CRP (C-Reactive Protein)Microgenics CorporationJJY2026-05-27
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489055TriVerity Level 2 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08