| Primary Device ID | 00840239035219 | 
| NIH Device Record Key | 8ede60cb-b37a-44f6-903c-a9430661b5e1 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Trichinella spiralis IgG ELISA | 
| Version Model Number | EIA-3521 | 
| Catalog Number | EIA-3521 | 
| Company DUNS | 075150847 | 
| Company Name | DRG International Inc | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | true | 
| Device Combination Product | false | 
| Single Use | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | true | 
| 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(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | |
| Phone | +1(973)564-7555 | 
| corp@drg-international.com | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840239035219 [Primary] | 
| MDT | ELISA, TRICHINELLA SPIRALIS | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-06-15 | 
| Device Publish Date | 2021-06-07 | 
| 00840239035219 | The Trichinella spiralis IgG ELISA test is a qualitative enzyme immunoassay for the detection of | 
| 00840239038661 | The Trichinella spiralis IgG ELISA is intended for the qualitative determination of IgG class an |