Identity
- Trade Name
- Vysis FDA UDI
- Generic Name
- Saline sodium citrate buffer IVD FDA UDI
- Device Name
- AutoFISH Reagent A (2X SSC) 500mL FDA UDI
- Model / Reference
- 07J82-001 FDA UDI
- Description
- AutoFISH Reagent A (2X SSC) 500mL FDA UDI
Identifiers
- Catalog Number
- 07J82-001 FDA UDI
- Primary DI / UDI-DI
- 00884999029330 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Saline sodium citrate buffer IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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: Saline sodium citrate buffer IVD
Vysis by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Vysis — Abbott Molecular · Class I
- Vysis — Abbott Molecular · 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
- Abbott Molecular
Sources (1)
- FDA UDI 65f26bf6-e64f-4f96-8c8e-ff7fff49454e 36 fields · synced Jun 6, 2026