Identity
- Trade Name
- Neonatal TSH Elisa FDA UDI
- Generic Name
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ELISA for the quantitative determination of Thyroid stimulating hormone (TSH) from a neonatal blood spot. FDA UDI
- Model / Reference
- 07594307 FDA UDI
- Description
- ELISA for the quantitative determination of Thyroid stimulating hormone (TSH) from a neonatal blood spot. FDA UDI
Identifiers
- Catalog Number
- 07594307 FDA UDI
- Primary DI / UDI-DI
- 00817830022412 FDA UDI
- 510(k) Number
- K913963 FDA UDI
- FDA Product Code
- JLW FDA UDI
- GMDN Term
- Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 25.5 Centimeter FDA UDI
Category: Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA)
Neonatal TSH Elisa by Mp Biomedicals, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neonatal thyroid stimulating hormone (neonatal TSH) IVD, kit, enzyme immunoassay (EIA).
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- N-TSH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
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- SPOTCHECK — ASTORIA-PACIFIC, INC. · Class II
- Neonatal Phenylalanine ELISA Kit (with membrane) — MP BIOMEDICALS, LLC · Class II
- Neonatal Phenylalanine ELISA Kit (with membrane) — MP BIOMEDICALS, LLC · Class II
Cleared under the same submission
K913963 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mp Biomedicals, Llc
Sources (1)
- FDA UDI c5c0196b-f106-49e9-86e8-98291ca95ea1 38 fields · synced May 30, 2026