FDA.reportPublic FDA data

HemoCue® WBC Analyzer

Primary DI
07311091230010
Brand
HemoCue® WBC Analyzer
Company
Hemocue AB
Model
123001
Catalog number
123001
Device description
HemoCue WBC Analyzer x10^9 /L
Published
2016-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GKLCounter, Cell, Automated (Particle Counter)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKLCounter, Cell, Automated (Particle Counter)Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071652000HEMOCUE WBC SYSTEMHemocue AB2007-10-25GKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07311091230010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07311091230010073110912300107311091230010

GMDN Terms#

Term, Definition table
TermDefinition
Haematological cell analyser IVD, semi-automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage in <90 % non-condensing humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
356164426
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17311091130034HemoCue® WBC Microcuvettes1130031130032016-05-31
17311091118148HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
27311091118077HemoCue® Hb 301 Microcuvettes1118141118142022-10-28
17311091118094HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
17311091118124HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
17311091107050HemoCue® Glucose 201 Microcuvettes1107051107052016-05-31
17311091107067HemoCue® Glucose 201 Microcuvettes1107061107062016-05-31
17311091107234HemoCue® Glucose 201 Microcuvettes1107231107232016-05-27
07311091207067HemoCue® Glucose 201 Analyzer1207061207062016-05-31
07311091207074HemoCue® Glucose 201 Analyzer1207071207072016-05-31
07311091214225HemoCue® Glucose 201 DM Analyzer1214221214222016-05-31
07311091214447HemoCue® Glucose 201 DM Analyzer1214441214442016-05-31
17311091218046HemoCue® Hb301 Analyzer1218041218042016-05-31
27311091118121HemoCue® Hb 301 Microcuvettes1118121118122022-08-30
07311091391681HemoCue® 801 Connect1391681391682019-04-25
17311091118070HemoCue® Hb 301 Microcuvettes1118071118072016-12-01
07311091218278HemoCue® Hb301 Analyzer1218271218272020-09-04
07311091118097HemoCue® Hb 301 Microcuvettes1118091118092020-09-04
07311091206237HemoCue® Albumin 201 Analyzer1206231206232019-04-25
17311091106084HemoCue® Urine Albumin Microcuvettes1106081106082019-04-25

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