FDA.reportPublic FDA data

Acquity

Primary DI
00816776020445
Brand
Acquity
Company
WATERS TECHNOLOGIES CORPORATION
Model
186015082IVD
Catalog number
186015082IVD
Device description
ACQUITY UPLC I-Class BSM (PLUS) IVD
Published
2022-03-01
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
00816776020445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816776020445008167760204458167760204450816776020445

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
00816776020315Acquity725000662IVD725000662IVD2021-10-06
00816776021473Xevo186011468IVD2026-07-07
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
00816776020452Acquity186015088IVD186015088IVD2022-03-01
00816776020469Acquity186015087IVD186015087IVD2022-03-01
00816776020476Acquity186015014IVD186015014IVD2022-03-01
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
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
00816776020025AcquityWATERS TECHNOLOGIES CORPORATIONLDM2021-10-01
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