FDA Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Ave, WO Bldg 71, 20993, Silver Spring, MD, United States
Visit website- Scope lines
- 7
- A2LA certificates
- 3
- Site in our directory
- 1
What this lab is accredited for
We could not match the method references in this lab’s scope to published test standard numbers. The full scope as published is below.
Only this lab. Searches the method, matrix and range of each of the 7 scope lines.
A2LA certificate 3042.01 · 3 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | Document 219; Document 226; Document 228; Document 231; Document 232; Document 430; Document 388; Document 575 | biological pharmaceuticals; in vitro diagnostic test kits | - |
| 2 | Document 220; Document 641; Document 651; Document 333; WO 75/3342 | M-M-R II Family of Vaccine Products | - |
| 3 | ISO/IEC 17025:2017 | - | - |
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
A2LA certificate 3042.02 · 2 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | Document 483; Document 476; Document 325; Document 527 | biological and pharmaceuticals | - |
| 2 | ISO/IEC 17025:2017 | - | - |
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
A2LA certificate 3042.03 · 2 lines
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | Documents 3004; 3005; Document 333 | Anti-Toxin Standards; Diphtheria Antitoxin; Tetanus Antitoxin; Seasonal Influenza Standards and Reagents; Reference Antigen Standard; Antiserum Reagents | See scope document |
| 2 | ISO 17034:2016 | - | - |
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Location
Accreditation data refreshed from the A2LA register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the A2LA entry linked above.