FDA.reportPublic FDA data

Pointe Albumin Reagent

Primary DI
00811727016003
Brand
Pointe Albumin Reagent
Company
HORIBA INSTRUMENTS INCORPORATED
Model
16-A7502-396
Catalog number
16-A7502-396
Device description
Pointe Albumin Reagent packaged for use on the Mindray BA800. 6 x 66ml. For the quantitative determination of Albumin in serum.
Published
2021-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CIXBromcresol Green Dye-Binding, Albumin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CIXBromcresol Green Dye-Binding, AlbuminClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822471000PSI ALBUMIN REAGENTPointe Scientific, Inc.,1982-09-14CIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727016003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727016003008117270160038117270160030811727016003

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of albumin in a clinical specimen, using a spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-445-9853techservice@medtestdx.com

Regulatory Flags#

DUNS number
052845583
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
00811727018977POINTE Chemistry Calibrator SetC7506-15C7506-152026-05-01
00811727015716Pointe ALT for the BS48014-A7526-37514-A7526-3752020-05-28
00811727015747Pointe BUN on BS48014-B7552-60014-B7552-6002020-05-28
00811727015761Pointe Creatinine Enzymatic on BS48014-C7548-21614-C7548-2162020-05-28
00811727015785Pointe Creatine Kinase for BS48014-C7522-22014-C7522-2202020-05-28
00811727015808Pointe Creatinine for BS48014-C7539-43214-C7539-4322020-05-28
00811727015822Pointe Direct Bilirubin for BS48014-HB936-20014-HB936-2002020-05-28
00811727015853Pointe HbA1c for the BS48014-H7546-16014-H7546-1602020-05-28
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654140Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2026-03-18
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCIX2025-05-28
00380740155346AlinityABBOTT IRELANDCIX2024-08-15
00380740155353AlinityABBOTT IRELANDCIX2024-08-15
00380740155872ARCHITECTABBOTT IRELANDCIX2024-08-15
00380740155889ARCHITECTABBOTT IRELANDCIX2024-08-15
00850053916007IDG/SanzayIDG/SANZAY CorporationCIX2023-12-18
10673486001013Albumin Reagent SetTECO DIAGNOSTICSCIX2023-07-07
10673486001020Albumin -BCG method TC-MatrixTECO DIAGNOSTICSCIX2023-07-07
00811727015693Pointe Albumin on BS480 AnalyzerHORIBA INSTRUMENTS INCORPORATEDCIX2020-05-28
10758750031771VITROSORTHO-CLINICAL DIAGNOSTICS, INC.CIX2020-05-16
03610230006825Yumizen C1200 AlbuminHORIBA ABX SASCIX2020-05-06
07613336120941Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
07613336120958Albumin Gen.2Roche Diagnostics GmbHCIX2020-03-05
00380740161644ARCHITECTAbbott GmbHCIX2019-11-15
00386100002145ALB Reagent KitMEDICA CORPORATIONCIX2019-02-14
00380740121716AlinityAbbott GmbHCIX2018-07-11
00852169008010ClearChem Diagnostics Inc. AlbuminCLEARCHEM DIAGNOSTICS INC.CIX2018-04-30
00817274022696JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2018-04-26
00630414596501Atellica CH AlbSiemens Healthcare Diagnostics Inc.CIX2017-12-22
05060500091682Synermed®INFRARED LABORATORY SYSTEMS LLCCIX2017-02-28
00817302022957CAROLINA LIQUID CHEMISTRIES CORP.® ALB REAGENT PRODUCT NO. DT224CAROLINA LIQUID CHEMISTRIES CORPORATIONCIX2016-10-17
00812137011848Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00081213701184Albumin ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CIX2016-10-12
00817274022313JAS DiagnosticsDREW SCIENTIFIC, INC.CIX2016-10-11
00817439020093Albumin / BS480Medtest Dx, Inc.CIX2016-09-27
00817439020109AlbuminMedtest Dx, Inc.CIX2016-09-27