| Primary Device ID | 04560189283923 |
| NIH Device Record Key | a11c58eb-4228-4137-935f-3152a903192a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemoglobin A1c Control Set |
| Version Model Number | N/A |
| Company DUNS | 690571724 |
| Company Name | TOSOH CORPORATION |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com | |
| Phone | 615-806-4671 |
| Isabelle.Lang-Zwosta@tosoh.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04560189283923 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-13 |
| Device Publish Date | 2026-01-05 |
| 04560189283923 - Hemoglobin A1c Control Set | 2026-01-13 |
| 04560189283923 - Hemoglobin A1c Control Set | 2026-01-13 |
| 04562185400571 - HbA1c Diluting Solution | 2026-01-13 |
| 04562185403060 - HbA1c Calibrator Set (S) | 2026-01-13 |
| 04562185404920 - Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | 2026-01-13 |
| 04562185404937 - 90 Sample Loader | 2026-01-13 |
| 04562185404944 - 290 Sample Loader | 2026-01-13 |
| 04562185405255 - TSKgel GR01 HbA1c Column | 2026-01-13 |
| 14562185405269 - GR01 HbA1c Elution Buffer No. 1 | 2026-01-13 |