| Items | Contents |
|---|---|
| Material | HbA1c Linearity control, level 1 - 15 |
| Volume | 1ml fill x 500 vials x 15 levels |
| Form | Liquid frozen or lyophilized |
| Shelf life | 1 year at -70°C after manufacture date (liquid frozen) 1 year at +2 -8°C after manufacture date (lyophilized) |
| Additive | Stabilizer |
| Lead time | Approx. 8-12 weeks |
| Level | HbA1c % | Hematocrit % | Hemoglobin (g/dl) |
|---|---|---|---|
| Level 1 | 5.6 – 6.0 | 20 | 7 |
| Level 2 | 7.6 - 8.0 | 20 | 7 |
| Level 3 | 9.7 – 10.3 | 20 | 7 |
| Level 4 | 5.6 – 6.0 | 40 | 13.5 |
| Level 5 | 7.6 - 8.0 | 40 | 13.5 |
| Level 6 | 9.7 – 10.3 | 40 | 13.5 |
| Level 7 | 5.6 – 6.0 | 60 | 20 |
| Level 8 | 7.6 - 8.0 | 60 | 20 |
| Level 9 | 9.7 – 10.3 | 60 | 20 |
| Level 10 | 5.6 – 6.0 | 33 – 35 | 11.0–11.7 |
| Level 11 | 7.6 - 8.0 | 33 – 35 | 11.0–11.7 |
| Level 12 | 9.7 – 10.3 | 33 – 35 | 11.0–11.7 |
| Level 13 | 5.6 – 6.0 | 50– 52 | 16.7 – 17.3 |
| Level 14 | 7.6 - 8.0 | 50– 52 | 16.7 – 17.3 |
| Level 15 | 9.7 – 10.3 | 50– 52 | 16.7 – 17.3 |
All units used in the manufacture of this product have been tested at the Blood Bank and were found negative by FDA approved tests for anti-HIV I/II, anti-HCV, STS, and non-reactive for HBsAg on a single donation basis. HIV-1 RNA and HCV RNA on NAT (minipool) tested according to FDA regulation and found non-reactive.
| Items | Contents |
|---|---|
| Vial | Brown or black glass vial |
| Vial cap | Color caps |
| Vial Labels | No Labels or label of your design |
| Transportation packaging | -70°C packaging (liquid frozen) +2 -8°C packaging (lyophilized) |
Specifications are customizable. Vial fill size, form, concentrations, markers, volume and number of levels.
