Vysis
- Primary DI
- 00884999042780
- Brand
- Vysis
- Company
- ABBOTT MOLECULAR INC.
- Model
- 04N02-021
- Catalog number
- 04N02-021
- Device description
- Vysis CLL FISH Probe Kit
- Published
- 2016-04-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Contact Domains#
abbottmolecular.comProduct Codes#
| Code | Name |
|---|---|
| PNK | Fluorescence in situ hybridization, chromosome 17p deletion (TP53) |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PNK | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) | Unknown | 3 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| P150041 | 000 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
| P150041 | 001 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
| P150041 | 002 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
| P150041 | 003 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
| P150041 | 004 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
| P150041 | 005 | VYSIS CLL FISH PROBE KIT | Abbott Molecular, Inc. | 2016-04-11 | PNK |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00884999042780 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00884999042780 | 00884999042780 | 884999042780 | 0884999042780 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | -25 Degrees Celsius | -15 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00884999051928 | Alinity m | 09N15-03C | 09N15-03C | 2026-07-27 |
| 00884999051737 | RealTime | 09R20-001 | 09R20-001 | 2026-07-06 |
| 00884999051744 | Alinity m | 09R20-002 | 09R20-002 | 2026-07-06 |
| 00884999051287 | Alinity m | 09N15-03B | 09N15-03B | 2026-04-13 |
| 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 |
| 00884999047853 | Alinity m | 09N26-002 | 09N26-002 | 2020-04-29 |
| 00884999047860 | Alinity m | 09N26-010 | 09N26-010 | 2020-04-29 |
| 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 |