| Primary Device ID | 00852223007188 | 
| NIH Device Record Key | d4b83fe2-5d5f-4123-bf25-46da0129a727 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SODIUM KIT | 
| Version Model Number | 2266-0 | 
| Catalog Number | 2266-0 | 
| 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 | 00852223007188 [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 |