Bond
For in vitro diagnostic use. BOND Ready-to-Use Primary Antibody PD-L1 (CAL10) is intended to be used for the qualitative identification by light microscopy of PD-L1 protein in…
For in vitro diagnostic use. BOND Ready-to-Use Primary Antibody PD-L1 (CAL10) is intended to be used for the qualitative identification by light microscopy of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) tissue by immunohistochemical staining. BOND Ready-to-Use Primary Antibody PD-L1 (CAL10) is optimized for use on the BOND-III fully automated system with BOND Polymer Refi ne Detection (DS9800) and BOND DAB Enhancer (AR9432). The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
7manufacturers in China registered for this device type
327catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jilin (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Shenzhen Dakewe BIO-Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shenzhen Dartmon Biotechnology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Fuzhou Maixin Biotech Co., Ltd. | Fuzhou | Fujian | Manufacturer | 3 |
Record
| Listed by | Leica Biosystems Newcastle Ltd, United Kingdom |
|---|---|
| FDA product code | NJT |
| Device type | Immunohistochemistry Reagents And Kits |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1860 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-28 |
| Record revised | 2025-02-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2025-02-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA0346-U | In distribution | |
| PA0562 | In distribution | |
| PA0493 | In distribution | |
| PA0103 | In distribution | |
| PA0090-U | In distribution | |
| PA0555-U | In distribution | |
| PA0373-U | In distribution | |
| PA0570 | In distribution | |
| PA0286 | In distribution | |
| PA0346 | In distribution | |
| PA0278 | In distribution | |
| PA0831 | In distribution | |
| PA0430 | In distribution | |
| PA0051 | In distribution | |
| PA0129-U | In distribution | |
| PA0354 | In distribution | |
| PA0777 | In distribution | |
| PA0360-U | In distribution | |
| PA0552 | In distribution | |
| PA0848-U | In distribution | |
| PA0347-U | In distribution | |
| PA0134 | In distribution | |
| PA0606 | In distribution | |
| PA0004 | In distribution | |
| PA0983-U | In distribution | |
| PA0387 | In distribution | |
| PA0848 | In distribution | |
| PA0026 | In distribution | |
| PA0410-U | In distribution | |
| PA0406-U | In distribution | |
| PA0027 | In distribution | |
| DS9713 | In distribution | |
| PA0181 | In distribution | |
| PA0226 | In distribution | |
| PA0681 | In distribution | |
| PA0339-U | In distribution | |
| PA0414-U | In distribution | |
| PA0473 | In distribution | |
| PA0308 | In distribution | |
| PA0169-U | In distribution | |
| PA0678-U | In distribution | |
| PA0532 | In distribution | |
| PA0163-U | In distribution | |
| PA0022 | In distribution | |
| PA0226-U | In distribution | |
| PA0996-U | In distribution | |
| PA0832 | In distribution | |
| PA0938 | In distribution | |
| PA0250 | In distribution | |
| PA0900 | In distribution | |
| PA0138-U | In distribution | |
| PA0554-U | In distribution | |
| PA0300-U | In distribution | |
| PA0708-U | In distribution | |
| PA0168 | In distribution | |
| PA0704 | In distribution | |
| PA0406 | In distribution | |
| DS9815 | In distribution | |
| PA0210-U | In distribution | |
| PA0938-U | In distribution | |
| PA0435-U | In distribution | |
| PA0155 | In distribution | |
| PA0354-U | In distribution | |
| PA0067-U | In distribution | |
| PA0435 | In distribution | |
| PA0193-U | In distribution | |
| PA0558 | In distribution | |
| PA0212 | In distribution | |
| PA0263-U | In distribution | |
| PA0909 | In distribution | |
| PA0219-U | In distribution | |
| DS9390 | In distribution | |
| PA0369-U | In distribution | |
| PA0443 | In distribution | |
| DS9494 | In distribution | |
| PA0488-U | In distribution | |
| PA0322 | In distribution | |
| PA0122 | In distribution | |
| PA0052-U | In distribution | |
| PA0493-U | In distribution | |
| PA0416 | In distribution | |
| PA0037-U | In distribution | |
| PA0131-U | In distribution | |
| PA0599-U | In distribution | |
| PA0449-U | In distribution | |
| PA0552-U | In distribution | |
| PA0022-U | In distribution | |
| PA0306 | In distribution | |
| PA0088-U | In distribution | |
| PA0273 | In distribution | |
| PA0942 | In distribution | |
| PA0570-U | In distribution | |
| PA0515 | In distribution | |
| PA0055 | In distribution | |
| PA0625-U | In distribution | |
| PA0427 | In distribution | |
| PA0014-U | In distribution | |
| PA0371-U | In distribution | |
| PA0101-U | In distribution | |
| PA0117-U | In distribution | |
| PA0562-U | In distribution | |
| PA0554 | In distribution | |
| PA0375-U | In distribution | |
| PA0019 | In distribution | |
| PA0300 | In distribution | |
| PA0539 | In distribution | |
| PA0379 | In distribution | |
| PA0046 | In distribution | |
| PA0727-U | In distribution | |
| PA0010-U | In distribution | |
| PA0373 | In distribution | |
| PA0473-U | In distribution | |
| PA0468-U | In distribution | |
| PA0286-U | In distribution | |
| PA0007 | In distribution | |
| PA0053 | In distribution | |
| PA0067 | In distribution | |
| PA0129 | In distribution | |
| PA0212-U | In distribution | |
| PA0169 | In distribution | |
| PA0168-U | In distribution | |
| PA0424-U | In distribution | |
| PA0571-U | In distribution | |
| PA0378-U | In distribution | |
| PA0291-U | In distribution | |
| PA0988-X | In distribution | |
| PA0088 | In distribution | |
| PA0273-U | In distribution | |
| PA0103-U | In distribution | |
| PA0834-U | In distribution | |
| PA0064-U | In distribution | |
| PA0790 | In distribution | |
| PA0555 | In distribution | |
| PA0713-U | In distribution | |
| PA0270 | In distribution | |
| PA0359 | In distribution | |
| PA0052 | In distribution | |
| PA0271-U | In distribution | |
| PA0035 | In distribution | |
| PA0055-U | In distribution | |
| PA0359-U | In distribution | |
| PA0905-U | In distribution | |
| PA0371 | In distribution | |
| PA0263 | In distribution | |
| PA0235-U | In distribution | |
| PA0777-U | In distribution | |
| PA0219 | In distribution | |
| PA0305-U | In distribution | |
| DS9665 | In distribution | |
| PA0031-U | In distribution | |
| PA0238-U | In distribution | |
| PA0977-U | In distribution | |
| PA0322-U | In distribution | |
| PA0057-U | In distribution | |
| PA0727 | In distribution | |
| PA0027-U | In distribution | |
| PA0620 | In distribution | |
| PA0249-U | In distribution | |
| PA0074 | In distribution | |
| PA0044 | In distribution | |
| PA0704-U | In distribution | |
| PA0410 | In distribution | |
| PA0420-U | In distribution | |
| PA0488 | In distribution | |
| PA0567-U | In distribution | |
| PA0305 | In distribution | |
| PA0963-U | In distribution | |
| PA0934 | In distribution | |
| PA0431-U | In distribution | |
| PA0114 | In distribution | |
| PA0163 | In distribution | |
| PA0310-U | In distribution | |
| PA0756-U | In distribution | |
| PA0233 | In distribution | |
| DS9800 | In distribution | |
| PA0216-U | In distribution | |
| PA0032 | In distribution | |
| PA0134-U | In distribution | |
| PA0200-U | In distribution | |
| PA0210 | In distribution | |
| PA0090 | In distribution | |
| PA0996 | In distribution | |
| PA0571 | In distribution | |
| PA0625 | In distribution | |
| PA0364-U | In distribution | |
| PA0989-X | In distribution | |
| PA0191-U | In distribution | |
| PA0204 | In distribution | |
| PA0640 | In distribution | |
| PA0122-U | In distribution | |
| PA0444 | In distribution | |
| PA0093 | In distribution | |
| PA0708 | In distribution | |
| PA0006-U | In distribution | |
| PA0640-U | In distribution | |
| PA0291 | In distribution | |
| PA0216 | In distribution | |
| PA0083 | In distribution | |
| PA0431 | In distribution | |
| PA0532-U | In distribution | |
| PA0427-U | In distribution | |
| DS9263 | In distribution | |
| PA0270-U | In distribution | |
| PA0183-U | In distribution | |
| PA0553-U | In distribution | |
| PA0094-U | In distribution | |
| PA0230 | In distribution | |
| PA0083-U | In distribution | |
| PA0050-U | In distribution | |
| PA0233-U | In distribution | |
| PA0610 | In distribution | |
| PA0200 | In distribution | |
| PA0364 | In distribution | |
| PA0424 | In distribution | |
| PA0693 | In distribution | |
| PA0035-U | In distribution | |
| PA0379-U | In distribution | |
| PA0906 | In distribution | |
| PA0037 | In distribution | |
| PA0416-U | In distribution | |
| PA0943 | In distribution | |
| PA0468 | In distribution | |
| PA0414 | In distribution | |
| PA0181-U | In distribution | |
| PA0374-U | In distribution | |
| PA0051-U | In distribution | |
| PA0044-U | In distribution | |
| PA0030-U | In distribution | |
| PA0799 | In distribution | |
| PA0114-U | In distribution | |
| PA0391 | In distribution | |
| PA0042-U | In distribution | |
| PA0558-U | In distribution | |
| PA0146 | In distribution | |
| PA0832-U | In distribution | |
| PA0171-U | In distribution | |
| PA0050 | In distribution | |
| PA0420 | In distribution | |
| PA0339 | In distribution | |
| PA0843-U | In distribution | |
| PA0991-X | In distribution | |
| PA0061-U | In distribution | |
| PA0235 | In distribution | |
| PA0905 | In distribution | |
| PA0016-U | In distribution | |
| PA0117 | In distribution | |
| PA0387-U | In distribution | |
| PA0963 | In distribution | |
| PA0118 | In distribution | |
| PA0014 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 2,453 |
| Thermo Scientific | Richard-Allan Scientific LLC | 866 |
| IHC | Slmp, LLC | 350 |
| Tissue-Tek Genie® | Sakura Finetek U.S.A., Inc. | 330 |
| Novocastra | Leica Biosystems Newcastle Ltd | 272 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 167 |
| Epredia | Richard-Allan Scientific LLC | 46 |
| Prame [EPR20330] | Biocare Medical, LLC | 14 |
| Cyclin D1 | Biocare Medical, LLC | 14 |
| Napsin A | Biocare Medical, LLC | 13 |
| Tissue-Tek Genie® DUO | Sakura Finetek U.S.A., Inc. | 13 |
| SOX10 (M) | Biocare Medical, LLC | 12 |
Showing 12 of 3,569. All products under Immunohistochemistry Reagents And Kits
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-07-31 | Class II | Process control | The affected lots of the product may contain a contaminant of fungus that can cause a loss of staining sensitivity and/or obstructions to fluid delivery to the slide. | 1) 2,304 units; 2) 37 units | 2017-08-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.