| Primary Device ID | 03701700824008 |
| NIH Device Record Key | 7f395460-2d22-4814-9122-9a3823462994 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ISE CALIBRATORS |
| Version Model Number | ISCA-0250 |
| Company DUNS | 267732378 |
| Company Name | VITALSCIENTIFIC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701700824008 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-08 |
| Device Publish Date | 2025-03-31 |
| 03701700821106 - HbA1c CALIBRATOR SET | 2026-01-27 |
| 03701700821205 - HbA1c CONTROL L+ H | 2026-01-27 |
| 03701700800019 - ENVOY 500 ALBUMIN REAGENT KIT | 2025-04-08 |
| 03701700800026 - ENVOY 500 ALT REAGENT KIT | 2025-04-08 |
| 03701700800033 - ENVOY 500 AMYLASE REAGENT KIT | 2025-04-08 |
| 03701700800040 - ENVOY 500 AST REAGENT KIT | 2025-04-08 |
| 03701700800057 - ENVOY 500 URIC ACID REAG.KIT | 2025-04-08 |
| 03701700800064 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT | 2025-04-08 |