Identity
- Trade Name
- Adsorb Out FDA UDI
- Generic Name
- DNA blocking reagent IVD FDA UDI
- Device Name
- To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays. FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays. FDA UDI
Identifiers
- Catalog Number
- ADSORB FDA UDI
- Primary DI / UDI-DI
- 00812117015255 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- DNA blocking reagent 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Category: DNA blocking reagent IVD
Adsorb Out by One Lambda, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as DNA blocking reagent IVD.
- 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
- One Lambda, Inc.
Sources (1)
- FDA UDI 1aed2d49-6c87-4a03-897d-204a4bd2c5db 36 fields · synced May 30, 2026