| Primary Device ID | 00817830022351 |
| NIH Device Record Key | 66427d57-9562-4ff5-bc2d-442aa7c4ac83 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neonatal Phenylalanine ELISA Kit (with membrane) |
| Version Model Number | 07575306 |
| Catalog Number | 07575306 |
| Company DUNS | 137825928 |
| Company Name | MP BIOMEDICALS, LLC |
| 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 | true |
| 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(800)854-0530 |
| custserv@mpbio.com | |
| Phone | +1(800)854-0530 |
| custserv@mpbio.com |
| Length | 25.5 Centimeter |
| Length | 25.5 Centimeter |
| 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 | 00817830022351 [Primary] |
| JNB | NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-20 |
| 00817830022351 | ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots. |
| 00817830022337 | ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots. |