Analyzers
These analyzers are used for disease testing for heart disease, cancer, diabetes, infectious diseases and hormonal disorders related to lifestyle.
Analyzers
These analyzers are used for disease testing for heart disease, cancer, diabetes, infectious diseases and hormonal disorders related to lifestyle.
Reagent
All reagents listed below MUST be used with an AFIAS analyzer.
C-peptide 510(k) Exempt
Measuring C-peptide levels and supporting the assessment of diabetes & hypoglycemia.
C-peptide is released from the pancreas in equal amounts with endogenous insulin and serves as a reliable marker of pancreatic beta-cell function. Measuring C-peptide helps assess the body’s insulin secretion capacity and distinguish endogenous insulin production from externally administered insulin. C-peptide testing is useful in evaluating diabetes, differentiating the causes of hypoglycemia, and assessing residual pancreatic function. It may also help identify insulin resistance and abnormalities in insulin secretion in individuals at risk of developing diabetes.
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Catalog Number: SMFP-187
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Estradiol 510(k) Exempt
Supporting the management and monitoring of Estrogen abnormalities with quantitative determination of Estradiol
Estradiol (17-β estradiol) is the primary ovarian hormone involved in the development of the female reproductive system. It is a form of estrogen that regulates various physiological functions, including ovulation and the development of female secondary sex characteristics. The test helps manage and monitor Estrogen abnormalities by providing quantitative results of Estradiol.
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Catalog Number: SMFP-184
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Follicle-stimulating Hormone (FSH) 510(k) Exempt
Diagnosis of early menopause & ovarian degeneration and infertility
This test can help figure out the cause of infertility, problems with ovarian functions, menstrual abnormalities and congenital or acquired gonadotropin development disorder or infertility.
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Catalog Number: SMFP-5
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
IGF-1 510(k) Exempt
Supporting the evaluation and monitoring of growth disorders
Insulin-like growth factor 1 (IGF-1) is a hormone that plays an important role in childhood growth and has anabolic effects in adults. It is produced primarily by the liver in response to growth hormone (GH) and serves as a principal mediator of GH activity. Quantitative measurement of IGF-1 in human serum or plasma can aid in the evaluation of growth disorders when interpreted together with clinical findings and other laboratory results.
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Catalog Number: SMFP-167
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Insulin 510(k) Exempt
Measuring insulin levels and supporting the diagnosis of diabetes & hypoglycemia
C-plin is a hormone produced by the pancreas, playing a crucial role in regulating blood sugar levels. In patients with type 2 diabetes, the production or utilization of insulin can be impaired, leading to abnormal blood sugar levels. Additionally, insulin testing is important in various situations, such as monitoring gestational diabetes and assessing the state of prediabetes. Notably, evaluating the state of prediabetes helps in early identification and preventive measures for individuals at high risk of developing diabetes, which is essential in delaying or preventing the onset of type 2 diabetes.
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Catalog Number: SMFP-174
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Luteinizing Hormone (LH) 510(k) Exempt
Assessing and monitoring function of pituitary gland
This test helps evaluate pituitary function by quantifying luteinizing hormone in the blood, to diagnose pituitary gland disease, and to determine congenitally or acquired gonadotropin dysfunction.
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Catalog Number: SMFP-6
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Microalbumin 510(k) Exempt
Screening for renal dysfunction
Microalbumin is quantitatively measured in random urine or concentrated first-morning urine to assess the extent of kidney damage and predict the progression of renal dysfunction. Regular monitoring helps guide appropriate treatment and evaluate the patient’s response to therapy.
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Catalog Number: SMFP-30
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
NORO 510(k) Exempt
A rapid and reliable assay for the precise detection of Norovirus antigens in fecal specimens.
Norovirus is highly transmissible via contaminated water and food sources (including seafood), serving as a primary pathogen in large-scale foodborne illness outbreaks. Early detection utilizing AFIAS ROTA assays facilitates the prevention of mass transmission and enables timely clinical intervention for optimal patient recovery.
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Target Indication: Norovirus gastroenteritis
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Catalog Number: SMFP-26
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
- 25 Samples Collection Tubes
Progesterone 510(k) Exempt
Monitoring ovulation abnormalities and predicting miscarriage & ectopic pregnancy
The progesterone test kit measures the level of progesterone in the blood. The progesterone test alone is not enough to diagnose a particular problem. But the result may help provide answers to causes of infertility, risk of miscarriage, ovulation, and ectopic pregnancy.
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Catalog Number: SMFP-94
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Prolactin (PRL) 510(k) Exempt
Assessment for diagnosing hypothalamic impairments & pituitary disorders
This test helps evaluate and diagnose mammary gland development, infertility treatment and pituitary diseases by quantifying blood PRL.
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Catalog Number: SMFP-8
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
ROTA 510(k) Exempt
A rapid and reliable assay for the precise detection of Rotavirus antigens in fecal specimens.
Rotavirus exhibits high infectivity even at minimal viral loads of fewer than 100 copies. It is a leading cause of severe acute gastroenteritis—particularly in infants and young children—presenting with frequent watery diarrhea, fever, vomiting, and abdominal pain. In severe cases, this can progress to critical, potentially fatal dehydration. Early diagnosis with AFIAS ROTA assays aids in mitigating community outbreaks and ensures prompt, targeted clinical management.
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Target Indication: Rotavirus Gastroenteritis
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Catalog Number: SMFP-25
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
- 25 Samples Collection Tubes
Rota/Adeno 510(k) Exempt
Rapid and accurate detection and differentiation of rotavirus and adenovirus antigens in fecal specimens.
Rotavirus is a leading cause of severe diarrheal disease in infants and young children under 2 years of age worldwide. Enteric adenovirus commonly causes gastroenteritis in children under 3 years of age, immunocompromised patients, and bone marrow transplant recipients. Differential diagnosis using the AFIAS Rota/Adeno assay may help reduce unnecessary antibiotic use and support appropriate clinical management.
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Target Indication: Rotavirus gastroenteritis, Adenovirus gastroenteritis
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Catalog Number: SMFP-43
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
- 25 Samples Collection Tubes
RSV 510(k) Exempt
An in vitro diagnostic assay intended to aid in the diagnosis of RSV infection.
RSV testing can help differentiate RSV infection from influenza and bacterial respiratory infections that may present with similar clinical symptoms. Accurate diagnosis may help reduce unnecessary or inappropriate antiviral and antibiotic use and support timely clinical management.
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Target Indication: Acute respiratory syncytial virus (RSV) infection
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Catalog Number: SMFP-126
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 24 Extraction buffer tubes
- 24 Nozzles
- 1 RSV negative control swab
- 1 RSV positive control swab
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
Strep A 510(k) Exempt
An in vitro diagnostic assay intended to aid in the diagnosis of Strep A infection.
Group A Streptococcus is highly contagious and can cause acute upper respiratory infections, including pharyngitis, as well as high fever and various complications. Prompt diagnosis and appropriate antibiotic treatment are important because reinfection and transmission can occur frequently. Rapid and sensitive detection of Group A Streptococcus may also help distinguish bacterial infection from other infections with similar symptoms, including viral infections.
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Target Indication: Group A streptococcal infection
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Catalog Number: SMFP-177
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Contents:
- 24 Cartridges
- 24 Extraction buffer tubes
- 24 Nozzles
- 24 Swabs
- 24 Pipette tips (zipper bag)
- 1 Strep A positive control swab
- 1 Strep A negative control swab
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
T3 510(k) Exempt
Supporting the diagnosis and treatment monitoring of thyroid disorders
The quantitative measurement of T3 in blood helps assess thyroid function, diagnose thyroid disorders, and guide appropriate treatment. Periodic measurement of T3 levels can also support the monitoring of treatment response.
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Catalog Number: SMFP-18
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use
T4 510(k) Exempt
Supporting the diagnosis and treatment monitoring of thyroid disorders
Rapid and accurate quantitative measurement of T4 in blood can help diagnose thyroid dysfunction and guide appropriate treatment. Serial measurements may also help monitor a patient’s response to treatment.
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Catalog Number: SMFP-19
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Contents:
- 24 Cartridges
- 24 Pipette tips (zipper bag)
- 1 Spare cartridge zipper bag
- 1 ID chip
- 1 Instructions for Use