BOND™
- Primary DI
- 05055331324801
- Brand
- BOND™
- Company
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Model
- PA0427
- Catalog number
- PA0427
- Device description
- CD4 (4B12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD4 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
- Published
- 2021-04-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
leicabiosystems.comProduct Codes#
| Code | Name |
|---|---|
| NJT | Immunohistochemistry Reagents And Kits |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NJT | Immunohistochemistry Reagents And Kits | Hematology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05055331324801 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05055331324801 | 05055331324801 | 5055331324801 |
GMDN Terms#
| Term | Definition |
|---|---|
| CD4 cell marker IVD, antibody | One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD4 cell marker in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)2480123 | tech.support@leicabiosystems.com |
Regulatory Flags#
- DUNS number
- 397134693
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05055331340900 | BOND | PA0404-U | PA0404-U | 2026-09-25 |
| 05055331340917 | BOND | PA0265-U | PA0265-U | 2026-09-25 |
| 05055331334725 | BOND™ | PA0258-U | PA0258-U | 2022-12-16 |
| 05055331315229 | Novocastra™ | CBE-356-L-CE | NCL-L-CBE-356 | 2022-12-07 |
| 05055331302038 | Novocastra™ | RE7120-CE | RE7120-K | 2021-05-17 |
| 05055331311788 | Novocastra™ | CK20-561-L-CE | NCL-L-CK20-561 | 2021-04-23 |
| 05055331304407 | BOND™ | PA0258 | PA0258 | 2021-04-16 |
| 05055331321206 | Novocastra™ | MSA-L-U | NCL-L-MSA | 2021-04-16 |
| 05055331303752 | BOND™ | PA0934 | PA0934 | 2021-04-09 |
| 05055331303783 | BOND™ | PA0906 | PA0906 | 2021-03-12 |
| 05055331330581 | BOND-PRIME | CS9300 | CS9300 | 2026-07-08 |
| 05055331339607 | BOND | PA0678-U | PA0678-U | 2026-04-10 |
| 05055331316967 | Novocastra™ | AE1/AE3-L-CE | NCL-L-AE1/AE3 | 2022-12-07 |
| 08718858480791 | Kreatech FISH probes | 22Q003B495 | 2022-09-21 | |
| 08718858481231 | Kreatech FISH probes | 02P009V550 | 2022-09-21 | |
| 08718858481248 | Kreatech FISH probes | 03Q009V495 | 03Q009V495 | 2022-09-21 |
| 08718858481774 | Kreatech FISH probes | 02P008V495 | 2022-09-21 | |
| 08718858481668 | Kreatech FISH probes | 03Q001B550 | 2022-08-08 | |
| 08718858481675 | Kreatech FISH probes | 03Q002B495 | 2022-08-08 | |
| 08718858481712 | Kreatech FISH probes | 13Q002C495 | 2022-08-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05055331340900 | BOND | LEICA BIOSYSTEMS NEWCASTLE LTD | NJT | 2026-09-25 |
| 05055331340917 | BOND | LEICA BIOSYSTEMS NEWCASTLE LTD | NJT | 2026-09-25 |
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| 00810119676016 | Anti-Beta-Tubulin III | BIOGENEX LABORATORIES | NJT | 2026-09-22 |
| 00810119679000 | Anti-Collagen III | BIOGENEX LABORATORIES | NJT | 2026-09-22 |
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