| Primary Device ID | 00844509001577 |
| NIH Device Record Key | c8eecf56-b43c-4fae-b1d7-d34674f3107f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CVA for CellDyn |
| Version Model Number | 291718 |
| Catalog Number | 291718 |
| Company DUNS | 072915986 |
| Company Name | STRECK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | false |
| Phone | 1-800-228-6090 |
| custserv@streck.com |
| Total Volume | 3 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844509001577 [Primary] |
| JPK | Mixture, Hematology Quality Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |
| 00844509001591 | Assayed linearity control kits that are used to determine the patient reportable range of 3-part |
| 00844509001584 | Assayed linearity control kits that are used to determine the patient reportable range of 3-part |
| 00844509001577 | Assayed linearity control kits that are used to determine the patient reportable range of 3-part |
| 00844509001560 | Assayed linearity control kits that are used to determine the patient reportable range of 3-part |