| Items | Contents |
|---|---|
| Material | HbA1c control, level 1 HbA1c control, level 2 |
| Volume | 0.5 – 2.0 ml fill x 100 – 50’000 vials (level 1) 0.5 – 2.0 ml fill x 100 – 50’000 vials (level 2) |
| Form | Liquid frozen or lyophilized |
| Shelf life | 2 years at -20°C after manufacture date (liquid frozen) 2 years at +2°C ~ +8°C after manufacture date (lyophilized) |
| Additive | Stabilizer |
| Lead time | Approx. 8 – 12 weeks |
| Storage and expiry date | Open vial stability: at least 1 month Less than ± 6% difference is the acceptable range from 0 time to open vial. |
| Level | HbA1c (%) | Hemoglobin (g/dl) |
|---|---|---|
| Level 1 | 5.0 – 5.5 | 14 – 15 |
| Level 2 | 10.0 – 10.5 | 14 – 15 |
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 glass |
| Vial cap | Color caps |
| Vial Labels | No Labels or label of your design |
| Transportation packaging | -20°C packaging (liquid frozen) |
| Additive | +2 -8°C packaging (lyophilized) |
Specifications are customizable. Vial fill size, form, concentrations, markers, volume and number of levels.
