FDA.report

Henry Schein

Primary DI
00304040103814
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701314
Catalog number
5701314
Device description
One Step + HB Starter Kit
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
00304040103814PrimaryGS10

GMDN Terms

TermDefinition
Total haemoglobin (totHb) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen, using a spectrophotometry method.

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
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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