Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)
Basic Information
- Brand Name
- Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)
- Primary DI
- 05055273219159
- Version / Model
- LAL10565
- Catalog Number
- LAL10565
- Company Name
- RANDOX LABORATORIES LIMITED
- Labeler DUNS
- 227530649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- 60c91b5f-589e-48ac-8f57-54de64720608
Device Description
The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total), Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin, Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids, Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen (CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose, Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a), Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin, Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC, Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12, Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
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
- Yes
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055273219159 | GS1 |
Customer Contacts
- Phone
- +442894451070
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -80 – -20 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius