Identity
- Trade Name
- Antiserum to Human Alpha 1 Acid Glycoprotein FDA UDI
- Generic Name
- Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent FDA UDI
- Device Name
- Goat antiserum to Human Alpha 1 Acid Glycoprotein FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Goat antiserum to Human Alpha 1 Acid Glycoprotein FDA UDI
Identifiers
- Catalog Number
- 123002 FDA UDI
- Primary DI / UDI-DI
- B1761230 FDA UDI
- 510(k) Number
- K831960 FDA UDI
- FDA Product Code
- LKL FDA UDI
- GMDN Term
- Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Category: Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent
Antiserum to Human Alpha 1 Acid Glycoprotein by Kent Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alpha-1-acid glycoprotein (orosomucoid) IVD, reagent.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Kent Laboratories, Inc.
Sources (1)
- FDA UDI 1cdee40b-d2c4-4bcb-bb34-e4ed6b2f5784 35 fields · synced May 31, 2026