FDA.reportPublic FDA data

Pointe Scientific, Inc.

Primary DI
00811727014528
Brand
Pointe Scientific, Inc.
Company
HORIBA INSTRUMENTS INCORPORATED
Model
H7504-500
Catalog number
H7504-500
Device description
Hemoglobin Reagent, for the quantitative determination of Hemoglobin in whole blood. Size: 1 x 500 mL
Published
2016-08-31
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
KHGWhole Blood Hemoglobin Determination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHGWhole Blood Hemoglobin DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K851432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851432000HEMOGLOBINPointe Scientific, Inc.,1985-07-12KHG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811727014528PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727014528008117270145288117270145280811727014528

GMDN Terms#

Term, Definition table
TermDefinition
Total haemoglobin (totHb) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) 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@medtest.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
04048534000840CleanerEKF-diagnostic GmbHKHG2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHKHG2022-12-21
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHKHG2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHKHG2021-05-10
00817869020052Hemoglobin AFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020069Hemoglobin NAFSC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020090Hemoglobin AS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020106Hemoglobin AC Control PowderANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020113Hemoglobin F Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020120Hemoglobin F Abnormal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020137Hemoglobin G6PDH Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020144Hemoglobin G6PDH Deficient ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020151Hemoglobin G6PDH Intermediate ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020168Hemoglobin Total Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020175Hemoglobin Total Linearity ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020182Hemoglobin A2 Normal ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020199Hemoglobin A2 Elevated ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020205Hemoglobin AE ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020212Hemoglobin FAS ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020229Hemoglobin AD ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00817869020236HemoglobinAG Philadelphia ControlANALYTICAL CONTROL SYSTEMS INCKHG2019-01-31
00657498000144STAT-Site M Hgb Analyzer PackSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000151STAT-Site M Hgb CardsSTANBIO LABORATORY, L.P.KHG2016-09-24
00657498000175STAT-Site M Hgb Code KeySTANBIO LABORATORY, L.P.KHG2016-09-24
05391516743136Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743143Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
05391516743150Trinity BiotechCLARK LABORATORIES, INC.KHG2016-09-19
00811727011466Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31