Colcemid Solution 9311

GUDID 00893727002415

Colcemid Solution

FUJIFILM IRVINE SCIENTIFIC, INC.

Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Primary Device ID00893727002415
NIH Device Record Key5c267aec-a5b0-437b-907b-c5cbd35ab44a
Commercial Distribution StatusIn Commercial Distribution
Brand NameColcemid Solution
Version Model Number9311-10ml
Catalog Number9311
Company DUNS057475246
Company NameFUJIFILM IRVINE SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com
Phone8004375706
Emailtmrequest@irvinesci.com

Device Dimensions

Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter
Total Volume10 Milliliter
Total Volume120 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857515006306 [Primary]
GS100893727002415 [Primary]

FDA Product Code

KIQKit, Culture, Chromosome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

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00893727002446 - Chang Medium B2021-04-29 CHANG Basal-90ml
00893727002453 - Chang Medium C2021-04-29 CHANG C L-100ml
00893727002460 - Chang Medium C2021-04-29 CHANG C L-500ml
00893727002484 - Chang Medium in SITU2021-04-29
00893727002767 - Chang Medium in SITU2021-04-29 Chang Medium in SITU
00857515006160 - Chang Medium MF with Gentamicin2021-04-27

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