| Primary Device ID | 40844509000523 |
| NIH Device Record Key | 4e86b61b-c009-4543-ba27-3138336a4d01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD-Chex Plus BC |
| Version Model Number | 213377 |
| Catalog Number | 213377 |
| 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 | |
| Phone | 1-800-228-6090 |
| custserv@streck.com |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 40844509000523 [Primary] |
| GGL | Control, White-Cell |
| 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 |
| 00844509000549 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 00844509000532 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 40844509000523 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 via |
| 40844509000516 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 5 vi |
| 30844509000526 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 30844509000519 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 2 vi |
| 20844509000529 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |
| 20844509000512 | A positive procedural control for monitoring immunophenotyping by flow cytometry. Contains 1 vi |