FDA.reportPublic FDA data

STAT-Site M Hgb Code Key

Primary DI
00657498000175
Brand
STAT-Site M Hgb Code Key
Company
STANBIO LABORATORY, L.P.
Model
901010
Catalog number
901010
Device description
The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.
Published
2016-09-24
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00657498000175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000175006574980001756574980001750657498000175

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
Device count
1
Lot or batch
true

Other Devices From This Company#

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Primary DIBrandModelCatalogPublished
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

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
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
00811727011473Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDKHG2016-08-31