FDA.report

HemoPoint® H2 n•x•t Microcuvettes

Primary DI
00657498000212
Brand
HemoPoint® H2 n•x•t Microcuvettes
Company
STANBIO LABORATORY, L.P.
Model
3016-050
Catalog number
3016-050
Device description
For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GKRSystem, Hemoglobin, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00657498000205PackageGS12In Commercial Distribution
00657498000212PackageGS14In Commercial Distribution
00657498001998PackageGS12In Commercial Distribution
00657498002001PackageGS14In Commercial Distribution
00657498301654PrimaryGS10
00657498301609Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000205006574980002056574980002050657498000205
00657498000212006574980002126574980002120657498000212
00657498001998006574980019986574980019980657498001998
00657498002001006574980020016574980020010657498002001
00657498301654006574983016546574983016540657498301654
00657498301609006574983016096574983016090657498301609

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags

DUNS number
045361136
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00657498002094Uri-Trak 120 M Urine AnalyzerG1300-001G1300-0012023-06-08
00657498002322HGB Controls - Low3061-0033061-0032021-03-31
00657498002339HGB Controls - Low3061-0063061-0062021-03-31
00657498002346HGB Controls - Normal3062-0033062-0032021-03-31
00657498002353HGB Controls - Normal3062-0063062-0062021-03-31
00657498002360HGB Controls - High3063-0033063-0032021-03-31
00657498002377HGB Controls - High3063-0063063-0062021-03-31
00657498001806Standard 1A469-97A469-972016-09-24
00657498000199HemoPoint H2 DMSG3500-001G3500-0012016-09-24
00657498000380Excel® Chemistry AnalyzerG7700E-001G7700E-0012018-04-17
00657498000397Excel® Chemistry Analyzer (Spanish)G7700S-001G7700S-0012018-04-17
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
27311091118077HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
04048534002165DiaSpect TmEKF-diagnostic GmbHGKR2022-10-17
27311091118121HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534002035Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
04048534002028Hemo ControlEKF-diagnostic GmbHGKR2021-05-10
04048534001946DiaSpect TmEKF-diagnostic GmbHGKR2021-03-11
24048534001964DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
07311091218278HemoCue® Hb301 AnalyzerHemocue ABGKR2020-09-04
07311091118097HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
00894472000237B CassetteOPTI MEDICAL SYSTEMS, INC.GKR2019-08-07
17311091119022HemoCue® Hb 801 MicrocuvettesHemocue ABGKR2019-02-06
07311091219206HemoCue® Hb 801 AnalyzerHemocue ABGKR2019-02-06
20304040103795Henry ScheinHENRY SCHEIN, INC.GKR2019-01-11
00304040103777Henry ScheinHENRY SCHEIN, INC.GKR2019-01-11
00304040103814Henry ScheinHENRY SCHEIN, INC.GKR2019-01-11
00304040103975Henry ScheinHENRY SCHEIN, INC.GKR2019-01-11
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerIMMUNOSTICS COMPANY, INCGKR2018-12-20
10722355003051hemochroma PLUS Starter KitIMMUNOSTICS COMPANY, INCGKR2018-12-20
05700699250476925-047 ABL90 FLEX inlet clipRadiometer Medical ApSGKR2018-09-21
20612479234103McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-09-01
20612479234080McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
20612479234110McKessonMCKESSON MEDICAL-SURGICAL INC.GKR2018-08-21
07311091117311HemoCue® Hb 201 MicrocuvettesHemocue ABGKR2018-05-25
07311091117328HemoCue® Hb 201 MicrocuvettesHemocue ABGKR2018-05-25
07311091118073HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2016-12-01
00657498000199HemoPoint H2 DMSSTANBIO LABORATORY, L.P.GKR2016-09-24
00657498000236n•x•t MicrocuvetteSTANBIO LABORATORY, L.P.GKR2016-09-24
00657498300039HemoPoint H2STANBIO LABORATORY, L.P.GKR2016-09-24