Hematek® Stain Pak - Wirght-Giemsa Stain 4405

GUDID 00630414473482

Hematek® Stain Pak Wright-Giemsa Stain

Siemens Healthcare Diagnostics Inc.

Biological stain IVD
Primary Device ID00630414473482
NIH Device Record Key527d00f8-2f03-4194-b45f-61794f3b8604
Commercial Distribution StatusIn Commercial Distribution
Brand NameHematek® Stain Pak - Wirght-Giemsa Stain
Version Model Number10314755
Catalog Number4405
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414473482 [Primary]

FDA Product Code

HYFGIEMSA STAIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

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00630414312460 - Atellica HEMA Cleaner2026-02-16 AT HEMA Cleaner
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Trademark Results [Hematek]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HEMATEK
HEMATEK
75589640 not registered Dead/Abandoned
SHOEMAKER, STEPHEN M.
1998-11-16

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