Identity
- Trade Name
- Sodium Citrate FDA UDI
- Generic Name
- Saline sodium citrate buffer IVD FDA UDI
- Model / Reference
- 100994 FDA UDI
Identifiers
- Catalog Number
- 100994 FDA UDI
- Primary DI / UDI-DI
- G0561009940 FDA UDI
- 510(k) Number
- K853077 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Saline sodium citrate buffer IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
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: Saline sodium citrate buffer IVD
Sodium Citrate by Bio/Data Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Saline sodium citrate buffer IVD.
- Vysis — Abbott Molecular · Class I
- SSC Wash Buffer — BIOCARE MEDICAL, LLC · Class I
- SSC Wash buffer — BIOCARE MEDICAL, LLC · Class I
- Vysis — Abbott Molecular · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- Vysis — Abbott Molecular · Class I
- DNA Hybridization Buffer — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio/Data Corp.
Sources (1)
- FDA UDI 53d40fe0-5b16-489e-adb0-6c0b473f3002 34 fields · synced May 30, 2026