Identity
- Trade Name
- BOND™ FDA UDI
- Generic Name
- Negative control immunoglobulin IVD FDA UDI
- Device Name
- Negative (Mouse) is intended to be used as a mouse negative control for qualitative immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
- Model / Reference
- PA0996-U FDA UDI
- Description
- Negative (Mouse) is intended to be used as a mouse negative control for qualitative immunohistochemical staining using the automated BOND system (includes BOND-MAX, BOND-III, and BOND-PRIME systems). FDA UDI
Identifiers
- Catalog Number
- PA0996-U FDA UDI
- Primary DI / UDI-DI
- 05055331335555 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Negative control immunoglobulin IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
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Combination Product
No
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HCT/P
No
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Premarket Exempt
Yes
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
Yes
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Manufacturing Date
No
FDA UDI
Category: Negative control immunoglobulin IVD
A comprehensive medical device directory listing the BOND device, including its features and specifications.
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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
- Leica Biosystems Newcastle, Limited
Sources (1)
- FDA UDI a0bfdccc-5aa2-4928-abaf-35c0355e5adc 36 fields · synced Jul 24, 2026