FDA.reportPublic FDA data

DiaSpect Hemoglobin Cuvettes

Primary DI
04048534001540
Brand
DiaSpect Hemoglobin Cuvettes
Company
DiaSpect Medical GmbH
Model
90C.0001
Device description
For the quantitative determination of hemoglobin in whole blood.
Published
2022-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKRSystem, Hemoglobin, Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048534001694PackageGS15In Commercial Distribution
04048534001540PrimaryGS10
04048534001687Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048534001694040485340016944048534001694
04048534001540040485340015404048534001540
04048534001687040485340016874048534001687

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
Special Storage Condition, Specify00Temperatures of -30°C up to +70°C temporarily permitted during transport (24 hrs max.)
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-531-5535techsupport@ekfdiagnostics.com
+4939203511414support@ekf-diagnostic.de

Regulatory Flags#

DUNS number
341050309
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048534001557DiaSpect Control Pack HBT190B.00112022-12-20
04048534001564DiaSpect Control Pack HBT290B.00122022-12-20
04048534001571DiaSpect Control Pack HBT390B.00132022-12-20
04048534001588DiaSpect Control Pack HBT490B.00142022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14048534002742CleanerEKF-diagnostic GmbHGKR2026-07-31
24048534002749CleanerEKF-diagnostic GmbHGKR2026-07-31
34048534002456Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
44048534002453Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2026-07-31
05700693930978ABL90 FLEXRadiometer Medical ApSGKR2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSGKR2026-07-09
05700699446572SP90Radiometer Medical ApSGKR2026-07-09
05700699447579SP90Radiometer Medical ApSGKR2026-07-09
05700699461056SC90Radiometer Medical ApSGKR2026-07-09
05700699461087SC90Radiometer Medical ApSGKR2026-07-09
05700699461094SC90Radiometer Medical ApSGKR2026-07-09
05700699461100SC90Radiometer Medical ApSGKR2026-07-09
05700699461131SC90Radiometer Medical ApSGKR2026-07-09
05700699461605SC90Radiometer Medical ApSGKR2026-07-09
05700699460509SC90 50 BG, LYT, MET, OXI + QCRadiometer Medical ApSGKR2024-07-01
04048534000840CleanerEKF-diagnostic GmbHGKR2022-12-21
04048534002189Add Pack Hemo Control DMEKF-diagnostic GmbHGKR2022-12-21
17311091118148HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
27311091118077HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-10-28
04048534002165DiaSpect TmEKF-diagnostic GmbHGKR2022-10-17
17311091118124HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
27311091118121HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2022-08-30
04048534000031Hemo Control Hemoglobin MicrocuvetteEKF-diagnostic GmbHGKR2021-05-10
14048534001967DiaSpect Tm CuvettesEKF-diagnostic GmbHGKR2021-03-11
17311091118094HemoCue® Hb 301 MicrocuvettesHemocue ABGKR2020-09-04
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.GKR2020-04-15
00894472000237B CassetteOPTI MEDICAL SYSTEMS, INC.GKR2019-08-07
10722355003020hemochroma PLUS MicrocuvettesImmunostics Company, IncGKR2018-12-20
10722355003044hemochroma PLUS Optical System CheckImmunostics Company, IncGKR2018-12-20
10722355003013hemochroma PLUS AnalyzerImmunostics Company, IncGKR2018-12-20