Chang Amnio 99473
GUDID 00893727002682
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| Primary Device ID | 00893727002682 |
| NIH Device Record Key | 90bb9def-25b6-4472-bbb8-b720e165a48f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Chang Amnio |
| Version Model Number | 99473-100ML |
| Catalog Number | 99473 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com | |
| Phone | 8004375706 |
| tmrequest@irvinesci.com |
Device Dimensions
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893727002682 [Primary] |
FDA Product Code
| KIQ | Kit, Culture, Chromosome |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-27 |
| Device Publish Date | 2021-04-19 |
On-Brand Devices [Chang Amnio]
| 00893727002699 | 99473-500ML |
| 00893727002682 | 99473-100ML |
Trademark Results [Chang Amnio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CHANG AMNIO 85458085 4369316 Live/Registered |
FUJIFILM IRVINE SCIENTIFIC, INC. 2011-10-27 |
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