DEVICE: Colcemid Solution (00893727002415)
Device Identifier (DI) Information
Colcemid Solution
9311-10ml
In Commercial Distribution
9311
FUJIFILM IRVINE SCIENTIFIC, INC.
9311-10ml
In Commercial Distribution
9311
FUJIFILM IRVINE SCIENTIFIC, INC.
Colcemid Solution
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60095 | Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent |
A substance or reactant intended to be used for the suspension, preservation and storage of amnioic fluid and/or chorionic villus sample (CVS) fluid of a clinical specimen, in order to maintain suitability for karyotyping or chromosome evaluation.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KIQ | Kit, Culture, Chromosome |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 10 Milliliter |
Device Record Status
5c267aec-a5b0-437b-907b-c5cbd35ab44a
May 03, 2021
1
April 23, 2021
May 03, 2021
1
April 23, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8004375706
tmrequest@irvinesci.com
tmrequest@irvinesci.com