HCG Test Pregnancy CE 510K Approval OEM David HCG Rapid 1 Step Pregnancy Test Card

• Classification: Test Strips & Test Tube
• Type: Imaging Diagnostic Equipment
• Certification: CE, FDA, EEC, MSDS, ISO13485
• Group: Middle-aged and Old
• OEM/ODM: Support
• Formats: Strip
• Model NO.: AMC22302-01
• Delivery Time: 30~60 Days
• Standard: Bp, Cp
• Transport Package: 50′ S / Box, 100boxes/ CTN
• Specification: CE, ISO
• Trademark: Shinepharm
• Origin: China
• HS Code: 90183220
• Production Capacity: 1000000 Boxes/Month

Product Description

Technical Specification:

Type:	HCG Test Strip
Function	Used for early diagnosis of pregnancy
Formats	Strip
Specimens	urine, serum / urine
Sensitivity	10MIU/ml, 12.5MIU/ml, 25MIU/ml
Accuracy	over 99.5%
Shelf life	24months from the manufacture
Storage	Room temperature
Certifications	CE &ISO13458
Packaging	50pcs/box, 100boxes/carton
Others	The kits can be made according to the customers∞ artwork or desig

Features:
1. Used for early diagnosis of pregnancy
2. Accurate, fast, simple & convenient
3. The kits can be made according to the customers∞ artwork or design

[Using the step]

1. Before opening the bag, please leave it at room temperature.

Take the test device out of the sealed bag and use it as soon as possible. The best results will be obtained if the measurement is performed within one hour.

2. Dispense 35 uL of serum/plasma or whole blood into the sample wells of the test card.

3. Dispense 1 drop of buffer directly from the buffer bottle, or use a calibrated pipette to transfer 40 uL of buffer to the sample well.

4. The result should be between 10 and 20 minutes, but not more than 30 minutes.

 

[Interpretation of Results]

NEGATIVE:

If only the quality control line C appears, and the test lines T1 and T2 are not purple/red, it indicates that no antigen is detected, and the result is negative.

POSITIVE:

Typhi antigen positive: If both the quality control line C and the test line T1 appear purple/red, it indicates that the typhi antigen is detected, and the result is positive for typhi antigen. Paratyphi A antigen positive: If both the quality control line C and the test line T2 appear purple/red, it indicates that the paratyphi A antigen is detected, and the result is positive for paratyphi A antigen. Typhi and paratyphi A antigen positive: If the quality control line C and the test lines T1 and T2 allappear purple/red, it indicates that the typhi and paratyphi A antigen are detected, and the result is positive for both typhi and paratyphi A antigen.

INVALID:

If the quality control line C is not displayed, the test result is invalid regardless of whether there is a purple/red test line, and it should be tested again.

 

 

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