Identity
- Trade Name
- Antiserum to Whole Human Serum FDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- Goat antiserum to Whole Human Serum FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Goat antiserum to Whole Human Serum FDA UDI
Identifiers
- Catalog Number
- 100002 FDA UDI
- Primary DI / UDI-DI
- B1761000 FDA UDI
- FDA Product Code
- DGR FDA UDI
- GMDN Term
- Plasma protein IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5700 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Plasma protein IVD, control
Antiserum to Whole Human Serum by Kent Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasma protein IVD, control.
- Alinity — Abbott Laboratories, Inc. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- Quality Club Specific IgE — Phadia GmbH · Class I
- K-ASSAY® ASO/RF/CRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- DImension Vista® Protein 1 Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH — Phadia GmbH · Class I
- DImension Vista® Cystatin C Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- EliA CCP Positive Control 100 — Phadia GmbH · Class II
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 acd0e1de-e111-4606-8b50-baaf9dd52b7e 34 fields · synced Jun 1, 2026