FDA UDI
In Commercial Distribution
🇺🇸 United States
ACL TOP 770
DI: 00195226000528
·
Model: 00000280057
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ACL TOP 770
- Primary DI
- 00195226000528
- Version / Model
- 00000280057
- Catalog Number
- 00000280057
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-15
- Public Version
- 2
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 708decb4-f436-4caf-923c-ecd3ec09a98e
Device Description
ACL TOP 770
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | Hematology | 864.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56689 | Coagulation analyser IVD, laboratory | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195226000528 | GS1 |
Customer Contacts
- Phone
- 800-678-0710
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius