FDA.report

Henry Schein

Primary DI
00304040103975
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701322
Catalog number
5701322
Device description
OneStepTM + Pro Hb Optical System Check
Published
2019-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GKRSYSTEM, HEMOGLOBIN, AUTOMATED

Product Code Classifications

CodeDeviceSpecialtyClass
GKRSystem, Hemoglobin, AutomatedHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040103975PrimaryGS10

GMDN Terms

TermDefinition
Total haemoglobin (totHb) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius35 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
1
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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00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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