| Primary Device ID | 00853931008016 |
| NIH Device Record Key | f936d9c2-06a1-4bda-8fa3-e61755ddeba9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glycated Hemoglobin (HbA1C) Analyzer IVD |
| Version Model Number | G8-90SLR |
| Catalog Number | 021561R |
| Company DUNS | 607696440 |
| Company Name | TOSOH BIOSCIENCE, INC. |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 6143171916 |
| kimberly.harmeson@tosoh.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853931008016 [Primary] |
| LCP | Assay, Glycosylated Hemoglobin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-06-08 |
| Device Publish Date | 2018-04-04 |
| 00853931008009 - Tosoh Automated Glycohemoglobin Analyzer HLC-723G8R | 2018-06-08 Glycated Hemoglobin (HbA1C) Analyzer IVD |
| 00853931008016 - Glycated Hemoglobin (HbA1C) Analyzer IVD | 2018-06-08Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured |
| 00853931008016 - Glycated Hemoglobin (HbA1C) Analyzer IVD | 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 90 Sample Loader, Remanufactured |
| 00853931008023 - Glycated Hemoglobin (HbA1C) Analyser IVD, 290 Loader, Remanufactured | 2018-06-08 Glycated hemoglobin (HbA1C) analyzer IVD, 290 Sample Loader, Remanufactured |
| 00853931008030 - Hemolysis and Wash Solution | 2018-06-08 Red Cell Lysing Reagent |