FDA.report

Hct Check - Low Level

Primary DI
08426950046653
Brand
Hct Check - Low Level
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009832350
Catalog number
00009832350
Device description
Hct Check - Low Level
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GLKCONTROL, HEMATOCRIT

Product Code Classifications

CodeDeviceSpecialtyClass
GLKControl, HematocritHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950046653PrimaryGS10
18426950046650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950046653084269500466538426950046653
1842695004665018426950046650

GMDN Terms

TermDefinition
Red blood cell count IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of red blood cell (erythrocyte) count and/or the calculation of intermediate red cell parameters in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Hct check controls are stable until the expiration date shown on the ampule label when stored at 15-25 °C
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags

DUNS number
557223252
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

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00195226000733GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX 450 Tests)000774450082023-10-02

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