Chang Medium B C100

GUDID 00893727002446

CHANG Basal-90ml

FUJIFILM IRVINE SCIENTIFIC, INC.

Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Primary Device ID00893727002446
NIH Device Record Key526f16a5-6f3d-4047-9b15-d86b4539a28c
Commercial Distribution StatusIn Commercial Distribution
Brand NameChang Medium B
Version Model NumberC100-90ML
Catalog NumberC100
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

Device Dimensions

Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 Milliliter
Total Volume90 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100893727002446 [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 Date2021-04-29
Device Publish Date2021-04-21

Devices Manufactured by FUJIFILM IRVINE SCIENTIFIC, INC.

00857515006658 - cryo-GO Vitrification Device2024-10-31 Red Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificatio
00857515006665 - cryo-GO Vitrification Device2024-10-31 Yellow Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica
00857515006672 - cryo-GO Vitrification Device2024-10-31 Blue Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificati
00857515006689 - cryo-GO Vitrification Device2024-10-31 Green Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificat
00857515006696 - cryo-GO Vitrification Device2024-10-31 Purple Vitrification Device (Pack of 10) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica
00857515006702 - cryo-GO Vitrification Device2024-10-31 Red Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificatio
00857515006719 - cryo-GO Vitrification Device2024-10-31 Yellow Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrifica
00857515006726 - cryo-GO Vitrification Device2024-10-31 Blue Vitrification Device (Pack of 50) cryo-GO Vitrification Device is a cryopreservation device intended for use in vitrificati

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.