| Primary Device ID | 00817869020083 |
| NIH Device Record Key | 3ebfff97-38e9-424c-b129-03f1ab6bb811 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemoglobin AC Control |
| Version Model Number | HC-105 |
| Catalog Number | HC-105 |
| Company DUNS | 038232682 |
| Company Name | ANALYTICAL CONTROL SYSTEMS INC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817869020083 [Primary] |
| GS1 | 10817869020080 [Package] Package: 6 pack [6 Units] In Commercial Distribution |
| KHG | Whole Blood Hemoglobin Determination |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-04 |
| Device Publish Date | 2019-01-31 |
| 00817869020359 - Hemoglobin Variant Control Kit | 2019-11-27 |
| 00817869020335 - Hemotec Whole Blood Control Kit Large | 2019-11-22 Whole Blood Control Kit containing 8 vials of each: SC-125, SC-126, and DW-101 |
| 00817869020342 - Hemotec Whole Blood Control Kit Small | 2019-11-22 Whole Blood Control Kit containing 2 vials of each: SC-125, SC-126, and DW-10 |
| 00817869020311 - Hemotec Whole Blood Control Kit Large | 2019-08-01 |
| 00817869020007 - .02M Calcium Chloride | 2019-03-04 |
| 00817869020014 - Slide Platelet Aggregation Test Reagent | 2019-03-04 |
| 00817869020052 - Hemoglobin AFSC Control | 2019-03-04 |
| 00817869020069 - Hemoglobin NAFSC Control | 2019-03-04 |