PathVysion
- Primary DI
- 00884999001756
- Brand
- PathVysion
- Company
- ABBOTT MOLECULAR INC.
- Model
- 02J01-035
- Catalog number
- 02J01-035
- Device description
- PathVysion HER-2 DNA Probe Kit
- Published
- 2014-11-20
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Contact Domains#
abbottmolecular.comProduct Codes#
| Code | Name |
|---|---|
| MVD | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MVD | System, Test, Her-2/Neu, Nucleic Acid Or Serum | Unknown | 3 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P980024 | 001 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 002 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 003 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 004 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 005 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 006 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 007 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 008 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 009 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 010 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 011 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 012 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 014 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 015 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 016 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 017 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 018 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 019 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
| P980024 | 020 | PATHVYSION HER-2 DNA PROBE KIT | Abbott Molecular, Inc. | 1998-12-11 | MVD |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00884999001756 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00884999001756 | 00884999001756 | 884999001756 | 0884999001756 |
GMDN Terms#
| Term | Definition |
|---|---|
| C-erbB2/Her2/neu oncoprotein IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Protect from light and humidity |
| Storage Environment Temperature | -20 Degrees Celsius | -20 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)553-7042 | customerservice@abbottmolecular.com |
Regulatory Flags#
- DUNS number
- 878263359
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
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| 00884999051690 | simpli-COLLECT | 09R16-001 | 09R16-001 | 2026-04-13 |
| 00884999052062 | Alinity m | 09N61-03B | 09N61-03B | 2025-11-20 |
| 00884999047846 | Alinity m | 09N26-001 | 09N26-001 | 2020-04-29 |
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| 00884999047426 | Alinity m | 09N26-012 | 09N26-012 | 2020-04-29 |
| 00884999047440 | Alinity m | 09N26-014 | 09N26-014 | 2020-04-29 |
| 00884999047464 | Alinity m | 09N26-016 | 09N26-016 | 2020-04-29 |
| 00884999047501 | Alinity m | 09N26-004 | 09N26-004 | 2020-04-29 |
| 00884999048096 | Alinity m | 09N26-019 | 09N26-019 | 2020-04-29 |
| 00884999048171 | Alinity m | 09N26-020 | 09N26-020 | 2020-04-29 |
| 00884999048034 | Alinity m | 08N53-002 | 08N53-002 | 2020-08-18 |
| 00884999031814 | m2000 | 9K15-01 | 9K15-01 | 2016-09-01 |
| 00884999049369 | Alinity m | 09N79-095 | 09N79-095 | 2025-06-27 |
| 00884999049376 | Alinity m | 09N79-085 | 09N79-085 | 2025-06-27 |
| 00884999049383 | Alinity m | 09N79-03A | 09N79-03A | 2025-06-27 |
| 00884999051348 | simpli-COLLECT | 09R02-001 | 09R02-001 | 2025-06-26 |
| 00884999051409 | simpli-COLLECT | 09N93-001 | 09N93-001 | 2025-06-26 |
| 30884999051349 | simpli-COLLECT | 09R02-001 | 09R02-001 | 2025-06-26 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00884999001732 | PathVysion | ABBOTT MOLECULAR INC. | MVD | 2014-11-20 |
| 00884999001763 | PathVysion | ABBOTT MOLECULAR INC. | MVD | 2014-11-20 |
| 05700572032465 | HER2 IQFISH pharmDx™ | AGILENT TECHNOLOGIES SINGAPORE PTE LTD | MVD | 2014-09-15 |