FDA UDI
In Commercial Distribution
🇺🇸 United States
Neonatal Phenylalanine ELISA Kit (without membrane)
DI: 00817830022344
·
Model: 07575305
·
MP BIOMEDICALS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neonatal Phenylalanine ELISA Kit (without membrane)
- Primary DI
- 00817830022344
- Version / Model
- 07575305
- Catalog Number
- 07575305
- Company Name
- MP BIOMEDICALS, LLC
- Labeler DUNS
- 137825928
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- eaa6a073-b25c-4b08-a130-7df708646782
Device Description
ELISA kit for the quantitative detection of phenylalanine in neonatal blood spots.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JNB | NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE | Clinical Chemistry | 862.1555 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54389 | Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of neonatal thyroid stimulating hormone (neonatal TSH) in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817830022344 | GS1 |
Customer Contacts
- Phone
- +1(800)854-0530
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K926106 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25.5 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius