Identity
- Trade Name
- Tinto IgD FDA UDI
- Generic Name
- Total immunoglobulin D (IgD total) IVD, antibody FDA UDI
- Device Name
- IgD is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- Predilute, 3 ml FDA UDI
- Description
- IgD is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
Identifiers
- Catalog Number
- BSB 5666 FDA UDI
- Primary DI / UDI-DI
- B502BSB56660 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Total immunoglobulin D (IgD total) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Total immunoglobulin D (IgD total) IVD, antibody
Tinto IgD by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin D (IgD total) IVD, antibody.
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- Antiserum to Human IgD (delta chain specific) — KENT LABORATORIES, INC. · Class II
- Poly Rb A-Hu IgD — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- IgD RID plate package — KENT LABORATORIES, INC. · Class I
- Poly Rb a Hu IgD/RPE, Rb F(ab')2 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Rabbit Monoclonal Anti-Human IgD Antibody, EP173 — EPITOMICS, INC. · Class I
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 |
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Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 266b33dc-edca-416b-97de-7db0ca84069e 34 fields · synced May 30, 2026