Identity
- Trade Name
- Annexin A10 (RPab) FDA UDI
- Generic Name
- Annexin A10 IVD, antibody FDA UDI
- Device Name
- Annexin A10 is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative FDA UDI
- Model / Reference
- BSB-3834-05 FDA UDI
- Description
- Annexin A10 is a purified immunoglobulin fraction of rabbit antiserum that is filtered, sterilized and diluted in buffer pH 7.5, containing BSA and sodium azide as a preservative FDA UDI
Identifiers
- Catalog Number
- BSB-3834-05 FDA UDI
- Primary DI / UDI-DI
- B502BSB3834050 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Annexin A10 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.5 Milliliter FDA UDI
Category: Annexin A10 IVD, antibody
Annexin A10 (RPab) by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Annexin A10 IVD, antibody.
- Tinto Annexin A10 (RPab) — BIO SB, INC. · Class I
- Tinto Annexin A10 (RPab) — BIO SB, INC. · Class I
- Annexin A10 (RPab) — BIO SB, INC. · Class I
- Tinto Annexin A10 (RPab) — BIO SB, INC. · Class I
- Annexin A10 (RPab) — BIO SB, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI a1cb16d4-89dd-44b8-93ee-5814d830068d 37 fields · synced Jun 1, 2026