| Primary Device ID | 00817869020281 |
| NIH Device Record Key | b86d3715-fdd0-4b93-a25d-6c01d1378573 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE Normal Control |
| Version Model Number | SC-131 |
| Catalog Number | SC-131 |
| 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 | false |
| 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 |
| Phone | 3178410458 |
| marielle@analyticalcontrols.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817869020281 [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 | 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 |