Identity
- Trade Name
- RDS FDA UDI
- Generic Name
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator FDA UDI
- Device Name
- RSV Test Kit European 135065 FDA UDI
- Model / Reference
- 10-RSV-065 FDA UDI
- Description
- RSV Test Kit European 135065 FDA UDI
Identifiers
- Catalog Number
- 10-RSV-065 FDA UDI
- Primary DI / UDI-DI
- 10694644700029 FDA UDI
- 510(k) Number
- K021789 FDA UDI
- FDA Product Code
- GQG FDA UDI
- GMDN Term
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3480 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
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: Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
Rds by American Bio Medica Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator.
- RDS — American Bio Medica Corp. · Class I
- Easy Lab Pro RSV — American Bio Medica Corp. · Class I
Cleared under the same submission
K021789 also covers:
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
- American Bio Medica Corp.
Sources (1)
- FDA UDI 92de1352-31c6-4bbe-b01e-f15a30e52ef1 37 fields · synced Jun 8, 2026