| Primary Device ID | 00857969006112 |
| NIH Device Record Key | 7338b8da-0709-453d-9f1e-fd00c913b74e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE |
| Version Model Number | SA1012 |
| Catalog Number | SA1012 |
| Company DUNS | 781990924 |
| Company Name | ALFA WASSERMANN, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | 973-852-0158 |
| HKatz@AlfaWassermannUS.com |
| Storage Environment Temperature | Between 18 Degrees Celsius and 26 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857969006112 [Primary] |
| CGX | Alkaline Picrate, Colorimetry, Creatinine |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 00857969006594 | HDL-C Reagent |
| 00857969006587 | Magnesium Reagent |
| 00857969006570 | Inorganic Phosphorus U.V. Reagent |
| 00857969006563 | γ-GT Reagent |
| 00857969006556 | ALT Reagent |
| 00857969006549 | Lipase Reagent |
| 00857969006532 | HDL-C Reagent |
| 00857969006525 | LDL-C Reagent |
| 00857969006518 | Uric Acid Reagent |
| 00857969006501 | Triglycerides Reagent |
| 00857969006495 | Total Iron Reagent |
| 00857969006488 | Cholesterol Reagent |
| 00857969006471 | LDL-C Reagent |
| 00857969006464 | Uric Acid Reagent |
| 00857969006457 | Triglycerides Reagent |
| 00857969006440 | Cholesterol Reagent |
| 00857969006419 | Urine Chemistry Controls |
| 00857969006365 | Starlyte III Fluid Pack |
| 00857969006358 | Urine Diluent |
| 00857969006341 | Starlyte Sodium Electrode Conditioner |
| 00857969006334 | Starlyte Cleaning Solution |
| 00857969006303 | Alkaline Phosphatase Reagent |
| 00857969006297 | Alkaline Phosphatase Reagent |
| 00857969006280 | LDH-L Reagent |
| 00857969006273 | T4 Reagent |
| 00857969006266 | BUN / UREA Reagent |
| 00857969006259 | AST Reagent |
| 00857969006242 | Hemoglobin A1c Reagent |
| 00857969006235 | Total Protein Reagent |
| 00857969006228 | Amylase Reagent |
| 00857969006211 | T4 Calibrators |
| 00857969006174 | AST Reagent |
| 00857969006167 | Ferritin Application Kit |
| 00857969006150 | Carbon Dioxide Reagent |
| 00857969006143 | CK Reagent |
| 00857969006136 | Albumin Reagent |
| 00857969006129 | Glucose Reagent |
| 00857969006112 | Creatinine Reagent |
| 00857969006105 | Calcium-Arsenazo Reagent |
| 00857969006099 | Total Bilirubin Reagent |
| 00857969006082 | Direct Bilirubin Reagent |
| 00857969006075 | CK Reagent |
| 00857969006068 | Creatinine Reagent |
| 00857969006020 | Direct Total Iron-Binding Capacity (TIBC) Reagent |
| 00857969006013 | LDL Cholesterol (LDL-C) Calibrator |
| 00857969006006 | KIT, DIRECT TIBC CALIBRATOR |
| 00857969006617 | Hemoglobin A1c Reagent |
| 00857969006655 | ISE CLEANING AND SODIUM ELECTRODE CONDITIONER |
| 00857969006648 | ISE WASH |
| 00857969006631 | SYSTEM DILUENT |