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
- The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyroid stimulating hormone from neonatal blood spot samples collected on Schleicher and Schuell’s filter paper #903. FDA UDI
- Model / Reference
- EIA-1483 FDA UDI
- Description
- The DRG Neonatal TSH ELISA kit is specifically designed to quantitate human thyroid stimulating hormone from neonatal blood spot samples collected on Schleicher and Schuell’s filter paper #903. FDA UDI
Identifiers
- Catalog Number
- EIA-1483 FDA UDI
- Primary DI / UDI-DI
- 00840239014832 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
- Not 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
Neonatal TSH ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- DRG International, Inc.
Sources (1)
- FDA UDI cc57ebb7-33b0-4dbe-b816-22473c5ec642 37 fields · synced May 30, 2026