FDA.report

Hct Calibrator

Primary DI
08426950046677
Brand
Hct Calibrator
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00009832550
Catalog number
00009832550
Device description
HCT CALIBRATOR 14 1600 SYNTH 50X2ML
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
JISCALIBRATOR, PRIMARY

Product Code Classifications

CodeDeviceSpecialtyClass
JISCalibrator, PrimaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08426950046677PrimaryGS10
18426950046674Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08426950046677084269500466778426950046677
1842695004667418426950046674

GMDN Terms

TermDefinition
Multiple haemoglogbin subtype IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple subtypes of haemoglobin in a clinical specimen, using an electrophoresis method.

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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