HCG Pregnancy Test Strip Kits with Ce FDA ISO Approved

• Classification: Biological Diagnostics
• Type: Urine Analyzer
• Certification: CE, FDA, ISO13485
• Group: Middle-aged and Old
• Medical Device Regulatory Type: Type 1
• Medical Devices Ad. Approval No.: Sdaa-20123609562
• Model NO.: HCG-U11
• Medical Devices Reg./Record No.: Sdaa-20123609562
• Transport Package: Individual Foil Pouch/ Customized Package
• Specification: Customized Package
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 200000PCS/Week

Product Description

HCG Pregnancy Test Strip Kits with CE FDA ISO Approved

Product Description

Product name	one step rapid HCG Pregnancy /LH ovulation Test Kit
Formats	strip/ cassette/ midstream
Size	2.5mm, 3.0mm, 3.5mm, 4.0mm, 5.0mm, 5.5mm, 6.0mm
Specimen	urine / serum
Certificate	CE FDA ISO
Sentivity	10miu, 20miu, 25miu
Accuracy	over 99%
Package	individual foil pouch
Result reading	within 5 minutes
Shelf time	3 years
Lead time	3-5 business days after payment confrimed, it also depend on your Qty
OEM service	Available
Sample	Available
Payment method	T/T, Western Union, Paypal , etc.

 

Detailed Packing

Type	Foil pouch-size/cm	package	box-size/cm	carton-size/cm	G.W
strip	11.5*5.5	100T/valve bag,5000T/carton	26*20	59*39*34	11KG
	11.5*5.5	100T/box,5000T/carton	20.8*12*5.7	62.5*43*32	13KG
	11.5*5.5	100T/valve bag,10000T/carton		70*47*40	20KG
	11.5*5.5	50T/box,10000T/carton	12*12*4.5	63*50*48
cassette	12*6	40T/box(),2000T/carton	22*12.5*6.5	65*45.5*34.5	17KG
	12*6	50T/box,2500T/carton	24*12.2*7.5	65*50*40	19KG
	12*6	25T/box,2000T/carton	17.8*12.5*5.5	71*42.5*52	19.8KG
	12*6	40T/valve bag,2000T/carton		53*53*34	16KG
midstream	18.8*5.5	1T/box,500T/carton	19*5.5*2.8	71.5*40*57.5	17KG
	18.8*5.5	20T/box,1000T/carton	19*12*6.5	64*45.5*34.5	18Kg
	18.8*5.5	50T/valve bag,2000T/carton		70*47*40	22KG
Sperm test		2 T/ box, 160T/carton	14*6.5*6	59*35*51	13KG

Test Procedure

Detailed Pictures





 

FAQ
Q1: What's the method u use to do the test?
A: Colloidal Gold Method.


Q2: What's ur MOQ ?
A: Always, for strip format, the MOQ is 5000pcs. While for cassette format, MOQ is 2000pcs, same as midstream.


Q3: What's ur packing of the tests?
A: If u choose the low cost, we will suggest you the bulk packing to go. Which means 1 test in a single pouch, then 100/40 pouches in a plastic bag, 50 bags in a carton. If u need to sell in pharmacy/chain shop or some countries which have strict requirements about the packing, u can choose to pack in a box, like 100pcs in a box, or even 1 test in a single box.


Q4: What's the main differences when comparing products from different suppliers?
A: U can compare the mainly features of the test: Accuracy, Sensitivity, Specificity, and then the Price.
 
Q5: Some tests can be tested with serum/plasma or with whole blood, so what's the difference?
A: Well, if the specimen is whole blood, people will need buffer, lancet and alcohol swab to help the test. If they buy all the accessories, they can test very easily at home. But if the specimen is serum/plasma, it will need centrifuge to separate serum from whole blood first. This way, it's better to use at lab or hospital. And in some words, serum/plasma test will always give a more accurate results.


Q6: How can i distinguish a good test kit?
A: U can judge from the 4facts:Technical data: Such as the accuracy, specificity and sensitivity.
Pouch sealing: Tight enough. If the foil pouch is not sealed well, the humidity in circustance will destroy the reactivity of antibodies labeled on NC membrane. Shelf life will be shorten down.

Flow speed: The shorter the better?? NO!! The reaction of antibodies on NC membrane and antigens in specimen usually requires quite a while to work sufficiently. You can refer to the instruction for more accurate time.

Background: Good test usually gives clean background after running. If there are red smears in the reading window, it usually caused by bad colloidal gold technology or bad NC membrane. Sometimes, the defect caused false positive result in practice