Identity
- Trade Name
- Glucagon RPab FDA UDI
- Generic Name
- Glucagon IVD, antibody FDA UDI
- Device Name
- Glucagon is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5 FDA UDI
- Model / Reference
- Concentrate, 0.5 ml FDA UDI
- Description
- Glucagon 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 5579 FDA UDI
- Primary DI / UDI-DI
- B502BSB55790 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Glucagon 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Glucagon IVD, antibody
Glucagon RPab by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Glucagon IVD, antibody.
- Rabbit Monoclonal Anti-Human Glucagon Antibody, EP74 — EPITOMICS, INC. · Class I
- Glucagon — BIOCARE MEDICAL, LLC · Class I
- Glucagon Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Glucagon — BIOCARE MEDICAL, LLC · Class I
- Rabbit Monoclonal Anti-Human Glucagon Antibody, EP74 — EPITOMICS, INC. · Class I
- Glucagon Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Glucagon Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Glucagon — BIOCARE MEDICAL, LLC · 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 fd6fee4e-4bde-4c67-b0eb-959a5947885e 34 fields · synced May 31, 2026