| Primary Device ID | 00817274022771 |
| NIH Device Record Key | 171ff4ef-1d33-4032-822e-88d825816b74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JAS Diagnostics |
| Version Model Number | AMY2-P1L |
| Catalog Number | AMY2-P1L |
| Company DUNS | 144968104 |
| Company Name | DREW SCIENTIFIC, 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 | 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 |
| Phone | 1-305-325-2300 |
| customerservice@erbadiagnostics.com | |
| Phone | 1-305-325-2300 |
| customerservice@erbadiagnostics.com | |
| Phone | 1-305-325-2300 |
| customerservice@erbadiagnostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817274022771 [Primary] |
| JFJ | Catalytic Methods, Amylase |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-20 |
| Device Publish Date | 2018-07-19 |
| 00817274022856 | HDL CHOLESTEROL (4x 125mL R1, 4x 42mL R2) |
| 00817274022849 | AMYLASE BULK LIQUID |
| 00817274022832 | GLUCOSE HEXOKINASE (2 x 125mL) |
| 00817274022825 | Microprotein Standard (1 x 10 mL) |
| 00817274022818 | Microprotein Standard |
| 00817274022801 | Microalbumin Multi-Calibrator (Levels A-F) |
| 00817274022795 | Microalbumin Control Kit (L1 & L2) |
| 00817274022788 | Microalbumin Reagent (4 x 20 mL R1, 2 x 10 mL) |
| 00817274022771 | AMYLASE Powder PALS (1 x1L) |
| 00817274022702 | CHOLESTEROL STD (1 X 1L) |
| 00817274022696 | ALBUMIN STANDARD (1x 1L) |
| 00817274022672 | UREA NITROGEN STANDARD (1x 1L) |
| 00817274022641 | LIPID CALIBRATOR (1 x 3 mL) UV |
| 00817274022634 | LIPID CALIBRATOR (1 x 3 mL) |
| 00817274022627 | OLYMPUS WASH SOLUTION - CONCENTRATE (6 x 2L) |
| 00817274022597 | LDL, (2 x 30 mL R1, 2 x 10mL R2) |
| 00817274022580 | Iron Liquid Reagent (2 x 125 mL R1, 1 x 15 mL R2) |
| 00817274022566 | TOTAL PROTEIN STANDARD (3mL) |
| 00817274022559 | CALCIUM Standard (1 x 1L) |
| 00817274022542 | GLUCOSE HEXOKINASE (1 x 1L) |
| 00817274022535 | Triglycerides Powder Bulk (20L) |
| 00817274022528 | TOTAL BILIRUBIN LIQUID (1 x 1L R1, 1 X 15 mL Sodium Nitrite) |
| 00817274022511 | DIRECT BILIRUBIN LIQUID (1 x 1L R1, 1 x 15 mL Sodium Nitrite) |
| 00817274022498 | CARBON DIOXIDE LIQUID 405nm (2x 125mL) |
| 00817274022481 | Phosphorus Liquid Reagent (2 x 125 mL) |
| 00817274022474 | TOTAL PROTEIN LIQUID REAGENT (1 x 1L) |
| 00817274022467 | Phosphorus Liquid Reagent (1 x 1L) |
| 00817274022450 | Calcium Arsenazo Reagent(1 x 1L) |
| 00817274022443 | Alkaline Phosphatase Bulk Liquid R1 2.5 L |
| 00817274022436 | Alkaline Phosphatase Bulk Liquid R1 10 L |
| 00817274022429 | ABS OLYMPUS WASH SOLUTION - CONCENTRATED (5 X 4L) |
| 00817274022382 | DGLab HDL/LDL CHOLESTEROL CALIBRATOR (3x 1mL) |
| 00817274022375 | LIPID CALIBRATOR (3x 1mL) |
| 00817274022368 | Chemistry Control Level 2 (5mL) |
| 00817274022351 | CHEMISTRY CONTROL LEVEL 1 ( 5mL) |
| 00817274022337 | CREATININE (5 x 50mL) |
| 00817274022320 | AMYLASE PALS BULK (20L CUBITAINER) |
| 00817274022313 | ALBUMIN BULK LIQUID (20 L Cubitainers) |
| 00817274022306 | HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 1 (3mL) |
| 00817274022290 | HDL/LDL CHOLESTEROL (LIPID) CONTROL LEVEL 2 (3mL) |
| 00817274022252 | HDL CHOLESTEROL (2x 125mL R1, 2x 42mL R2) |
| 00817274022245 | IRON STANDARD BULK |
| 00817274022221 | XL-400 Clinical Chemistry Analyzer |
| 00817274022214 | XL-200 Clinical Chemistry Analyzer |
| 00817274022207 | URIC ACID STANDARD (1x 3mL) UV |
| 00817274022191 | URIC ACID REAGENT PALS BULK (in 20 dry Liter bottles) |
| 00817274022184 | URIC ACID LIQUID REAGENT (1x 1L) |
| 00817274022177 | URIC ACID LIQUID (2x 125mL + 1x 3mL Standard) |
| 00817274022160 | URIC ACID LIQUID (1 x 1 Liter + 1 x 5mL Standard) |
| 00817274022153 | URIC ACID LIQ BULK (in 20L cub) |