Vysis
- Primary DI
- 00884999011694
- Brand
- Vysis
- Company
- ABBOTT MOLECULAR INC.
- Model
- 05J38-010
- Catalog number
- 05J38-010
- Device description
- AneuVysion DNA Probe Kit
- Published
- 2016-09-01
- 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 |
|---|---|
| OYU | Dna-probe kit, human chromosome |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| OYU | Dna-Probe Kit, Human Chromosome | Immunology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K010288 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00884999011694 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00884999011694 | 00884999011694 | 884999011694 | 0884999011694 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple congenital aneuploidy screening IVD, probe | A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple congenital aneuploidies, including (but not limited to) trisomy 13 (Pätau syndrome), trisomy 18 (Edwards syndrome), trisomy 21 (Down syndrome), and sex chromosome aneuploidies. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Store unopened kit protected from light and humidity. Store 20X SSC salts and NP - 40 at room temperature. Avoid kit components exposed to light, heat, or humidity. |
| 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 |
|---|---|---|---|---|
| 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 |
| 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 |
|---|---|---|---|---|
| 00884999027077 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-10 |
| 00884999011663 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999011700 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999011717 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999011731 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999027008 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999027039 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999027046 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2016-09-01 |
| 00884999001831 | PathVysion | ABBOTT MOLECULAR INC. | OYU | 2014-11-20 |
| 00884999001855 | PathVysion | ABBOTT MOLECULAR INC. | OYU | 2014-11-20 |
| 00884999002128 | UroVysion | ABBOTT MOLECULAR INC. | OYU | 2014-11-20 |
| 00884999025721 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2014-11-20 |
| 00884999025738 | Vysis | ABBOTT MOLECULAR INC. | OYU | 2014-11-20 |