| Primary Device ID | 00852223007218 |
| NIH Device Record Key | 97d26350-f648-4604-9e89-c0ac7ce0ee7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOTAL AND DIRECT BILIRUBIN |
| Version Model Number | 2130-0 |
| Catalog Number | 2130-0 |
| Company DUNS | 155284151 |
| Company Name | STERLING DIAGNOSTICS 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852223007218 [Primary] |
| 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 | 2016-09-14 |
| 00852223007119 - UREA NITROGEN (BERTHELOT) | 2018-04-17 UREA NITROGEN/COLOR (BERTHELOT) |
| 00852223007126 - UREA NITROGEN (BERTHELOT) | 2018-04-17 UREA NITROGEN (BERTHELOT) |
| 00852223007003 - ENZYMATIC CHOLESTEROL | 2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH) |
| 00852223007010 - ENZYMATIC CHOLESTEROL | 2018-03-29 ENZYMATIC CHOLESTEROL (TRINDER/COD-CEH) |
| 00852223007027 - HDL CHOLESTEROL | 2018-03-29 HDL CHOLESTEROL (PEG METHOD) |
| 00852223007034 - CPK / COLORIMETRIC | 2018-03-29 CREATINE PHOSPHOKINASE (CPK) COLORIMETRIC |
| 00852223007041 - CREATININE/ ENDPOINT | 2018-03-29 CREATININE/ENDPOINT |
| 00852223007058 - ENZYMATIC GLUCOSE | 2018-03-29 GLUCOSE ENZYMATIC TRINDER |