FDA.reportPublic FDA data

Acquity

Primary DI
00816776020025
Brand
Acquity
Company
WATERS TECHNOLOGIES CORPORATION
Model
186015000IVD
Catalog number
186015000IVD
Device description
ACQUITY UPLC I-Class BSM, IVD
Published
2021-10-01
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
LDMInstrumentation, High Pressure Liquid Chromatography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDMInstrumentation, High Pressure Liquid ChromatographyClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816776020025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020025008167760200258167760200250816776020025

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument designed for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. Chemical components are separated by passing pressurized liquid through a narrow column to allow the various components to separate based on their chemical/physical properties while interacting with column filling. As the substances exit the column they are detected and identified electronically or spectrometrically. The device is used for the identification of complex substances such as drugs and hormones. It operates with reduced technician involvement and automation of some procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-252-4752customerservice@waters.com

Regulatory Flags#

DUNS number
107186004
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing 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
00816776020438MassTrak186009312IVD186009312IVD2021-10-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03610522126750D-10BIO-RAD LABORATORIES, INC.LDM2023-06-12
00847817003516D-10BIO-RAD LABORATORIES, INC.LDM2023-01-31
00847817006098D-10BIO-RAD LABORATORIES, INC.LDM2023-01-31
00847817014949VARIANT IIBIO-RAD LABORATORIES, INC.LDM2023-01-31
00847817015786VARIANT II TURBOBIO-RAD LABORATORIES, INC.LDM2023-01-31
03610522060696D-100BIO-RAD LABORATORIES, INC.LDM2023-01-31
00816776020445AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020452AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020469AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020476AcquityWATERS TECHNOLOGIES CORPORATIONLDM2022-03-01
00816776020315AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-06
00816776020087AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020094AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020100AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020117AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-04
00816776020032AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020049AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020063AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00816776020070AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
00847817007163Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.LDM2020-07-01
00847817006791Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.LDM2020-06-24