CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test
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Product Highlights
- High Accuracy and Sensitivity: Accuracy over 98.2%, Sensitivity 98.1%, Specificity 98.2% for reliable results.
- CE and ISO13485 Certified: Product holds CE and ISO13485 certificates for quality and safety assurance.
- Rapid 10-Minute Results: Read results quickly at 10 minutes; do not interpret after 20 minutes.
- OEM Customization Available: OEM service available with a lead time of 20 days.
- Easy Home and Clinical Use: Designed for laymen with fingerstick whole blood testing protocol.
- Comprehensive Diagnostic Utility: Used to diagnose thyroid disorders and evaluate pituitary gland function.
- Fast Production Lead Time: Peak and off-peak season lead time within 15 workdays.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent
- Accuracy
- 98.2%
- Model NO.
- ST-1003
- Format
- Cassettes
- Product Name
- Thyroid Stimulating Hormone Test
- Specificity
- 98.2%
- Sensitivity
- 98.1%
- Usage
- Home Use and Clinical Use
- Transport Package
- Carton
- Trademark
- SD
- Origin
- Hangzhou
- HS Code
- 3822190090
- Production Capacity
- 300000PCS/Day
Product Images of CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test
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CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test -
CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test -
CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test -
CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test -
CE Approved Tsh Whool Blood Thyroid Stimulating Hormone Rapid Test
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Product Description
CE Approved TSH Whool Blood Thyroid Stimulating Hormone Rapid Test
Purpose of the TSH test
Your TSH level provides information about whether your thyroid gland is functioning normally. TSH is often tested as part of a thyroid panel, along with tests of hormones produced by the thyroid gland. If TSH alone is tested and the result is abnormal, additional thyroid tests may be ordered.
When should I get a TSH test?
TSH testing is used to:
1.Diagnose and monitor the treatment of a thyroid disorder
2. Help evaluate pituitary gland function
TSH Test parameter:
| Produt name | Thyroid Stimulating Hormone (TSH) Rapid Test |
| Sensitivity | 98.1% |
| Specificity | 98.2% |
| Accuracy | More than 98.2% |
| Shelf time | 24-36 month |
| OEM time | 20 days |
| Certificate | CE/ISO13485 |
| Specimen | blood |
| Format | cassette |
| Usage | Read results at 10 minutes |
| Storage Temperature | 2-30°C |
Feature:
Fast: 10 minutes
Reliable: Tested for efficacy
Easy: Can be performed by layman
Confidential: Can be performed in privacy
All test components: No other materials required
Convenient: Fingerstick whole blood test protocol
Picture Display:
TEST PROCEDURE:
1. Wash your hands with soap and rinse with clear warm water.
2. Bring the pouch to room temperature before opening it. Open the foil pouch and get out the cassette.
3. Carefully pull off and dispose the released cap of the lancet.
4. Use the provided alcohol pad to clean the fingertip of the middle or ring finger as the puncture site.
5. Press the lancet, on the side from where the cap was extracted; against the fingertip (Side of ring finger is advised). The tip retracts automatically and safely after use.
6. Keeping the hand down massage the end that was pricked to obtain a blood drop.
7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood if the line is not reached. Avoid air bubbles.
8. Put the blood collected into the sample well of the cassette, by squeezing on the dropper bulb.
9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the sample well of the cassette.
10.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
2. Bring the pouch to room temperature before opening it. Open the foil pouch and get out the cassette.
3. Carefully pull off and dispose the released cap of the lancet.
4. Use the provided alcohol pad to clean the fingertip of the middle or ring finger as the puncture site.
5. Press the lancet, on the side from where the cap was extracted; against the fingertip (Side of ring finger is advised). The tip retracts automatically and safely after use.
6. Keeping the hand down massage the end that was pricked to obtain a blood drop.
7. Without squeezing the capillary dropper bulb, put it in contact with the blood. The blood migrates into the capillary dropper to the line indicated on the capillary dropper. You may massage again your finger to obtain more blood if the line is not reached. Avoid air bubbles.
8. Put the blood collected into the sample well of the cassette, by squeezing on the dropper bulb.
9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the sample well of the cassette.
10.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
Interpreting results:
POSITIVE: Two colored lines appear. Both T (Test) and C (Control) line appear.
This result means that the TSH level is higher than the normal, and that you should consult a physician.
NEGATIVE: One colored line appears. Only control line (C) appears.
This result means that the TSH level is not in the range to consider Hypothyroidism.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely
reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue
using the test kit immediately and contact your local distributor.
This result means that the TSH level is higher than the normal, and that you should consult a physician.
NEGATIVE: One colored line appears. Only control line (C) appears.
This result means that the TSH level is not in the range to consider Hypothyroidism.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely
reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue
using the test kit immediately and contact your local distributor.
| Product Name | Specimen | Format | Package Size |
| One Step Thyroid Stimulating Hormone Test | blood | cassette | 1Test/foil pouch, 1Test/box |
Shipping:
By ship, plane or express according to quantity
One Step Fertility & Eugenic Test Products Profile
|
Product
|
Specimen
|
Type
|
Sensitivity
|
|
Pregnancy HCG Test Kit
|
Urine/Serum
|
strip/cassette/midstream
|
25mIU/ml
|
|
Digital Pregnancy Test Kit
|
Urine
|
midstream
|
25mIU/ml
|
|
Ovulation (LH) Test Kit
|
Urine
|
strip/cassette/midstream
|
25mIU/ml
|
|
FSH(Follicle-stimulating Hormone)
|
Urine
|
strip/cassette/midstream
|
25mIU/ml
|
|
fFN(Fetal Fibronectin)
|
cervical mucus
|
strip/cassette
|
25ng/ml
|
|
Sperm-density
|
Semen
|
cassette
|
N/A
|
|
HSV I lgG/lgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
HSV II lgG/lgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
HSV 1+2 lgG/lgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
TOXO IgG/IgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
RV IgG/IgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
CMV IgG/IgM
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
TORCH IgM combo-5
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
|
TORCH IgG/IgM combo-5
|
whole blood/ serum/plasma
|
cassette
|
N/A
|
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASI229778". Items marked "
" are certified.
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Company Profile
Henan Season Medical Device Co., Ltd. is committed to providing point-of-care testing (POCT) products in the biomedical in vitro diagnostic (IVD) industry, we focus on Rapid Self Tesing: Fertility Tests, Digital Pregnancy Test, Drug of Abuse Rapid Test, Alcohol Rapid Test, Urine Rapid Test.
We have 10 years of experience in medical testing and prevention and control.
In 2020, Season Medical Began to focus on the diagnosis and treatment Products and services include rapid detection of colloidal gold, nucleic acid diagnosis, and Chinese medicine prevention and treatment.
ISO9001, ISO13485 approved, and our products received certification and approval from CE in Europe and FDA in United States.
Our Product
The product we Carry:
Syphilis Self Test
H. Pylori Antigen Rapid Test (Self-Testing)
Fecal Occult Blood (FOB) Rapid Test
Kidney Albumin Urine Test
Vaginal pH Rapid Test
Vitamin D Rapid Test (Self-Testing)
Sperm Concentration Rapid Test (Self-Testing)
Group A Streptococcus Antigen Test
Urine Analysis Rapid Test
Drug of Abuse Rapid Test
Alcohol Rapid Test
Fertility Test:
Digital Reusable Pregnancy Test
Digital Reusable Ovulation Test
Dual Function Digital Reusable Pregnancy&Ovulation Test
(HCG)Pregnancy Test
(LH) Ovulation Test
(FSH) Follicle Stimulating Hormone Test
Certificate:
ISO9001, ISO13485 approved, and our products received certification and approval from CE in Europe and FDA in United States.
Pacakge:
OEM Pacakge appreciate.
What we can do
Our Main work is to offer our customers Self test in China, and offer our customers correct products, better configuration and better price.
I think we are not only sell tests to our customers, but find better solution for them
About Our Factory & Business Background
- Address
- No. 18 Commerce Outer Ring Road, Zhengdong New District, Zhengzhou, Henan, China
- Terms of Payment
- T/T, PayPal, Western Union, Money Gram
- International Commercial Terms(Incoterms)
- FOB, EXW, CFR, CIF, DDP, DAP, FCA
- Average Lead Time
-
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays - Nearest Port
- Shanghai, TIANJIN
Our Production Capability & Technical Expertise
Our Industry Experience & Global Business Record
- Export Year
- 2005-08-05
- Main Markets
- North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe
FAQ
- What is the accuracy of the TSH test?
- The test has an accuracy of more than 98.2%, with sensitivity at 98.1% and specificity at 98.2%.
- How long does it take to get results?
- Results can be read at 10 minutes. Do not interpret the result after 20 minutes.
- Is OEM service available for this product?
- Yes, OEM customization is available with a lead time of 20 days.
- What certificates does the product hold?
- The product is CE approved and holds ISO13485 certification.
- How should I interpret a positive result?
- A positive result shows two colored lines (T and C), indicating TSH levels are higher than normal; consult a physician.
- What is the lead time for production?
- The average lead time is within 15 workdays for both peak and off-peak seasons.
- Can this test be used at home?
- Yes, it is designed for home use and clinical use, performable by laymen with fingerstick whole blood.
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Product Groups
- Digital Pregnancy Test
- Vitamin D Rapid Test
- Syphilis Home Test
- Urinary Tract Infection(UTI) Self Test
- Thyroid Stimulating Hormone (TSH) Rapid Test
- Ferritin Rapid Test
- Vaginal pH Self Test
- H. pylori Antigen Rapid Test
- Fecal Occult Blood (FOB) Rapid Test
- Male Fertility Test
- Fertility Test
- Kidney Albumin Test
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