FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc.
DI: 00811727014337
·
Model: 13-L7572-R2-125
·
HORIBA INSTRUMENTS INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pointe Scientific, Inc.
- Primary DI
- 00811727014337
- Version / Model
- 13-L7572-R2-125
- Catalog Number
- 13-L7572-R2-125
- Company Name
- HORIBA INSTRUMENTS INCORPORATED
- Labeler DUNS
- 052845583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2025-10-02
- Public Version Status
- Update
- Public Device Record Key
- 50bf3ecd-d174-4329-8055-6b31a067785b
Device Description
Lactate Dehydrogenase (LD/LDH) Reagent, for the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum. Size: 1 x 125 mL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | Clinical Chemistry | 862.1440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53074 | Total lactate dehydrogenase (LDH) 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 quantitative measurement of total lactate dehydrogenase (LDH) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727014337 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973589 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius