 | | RAPID TESTS |
Wondfo Biotech Co., Ltd custom designs and manufactures:
- Rapid Tests and Immunodiagnostic Reagents
- Finished OEM products ready for distribution
The two main lines of manufactured clinical products are Rapid Tests and Immunodiagnostic Reagents. Both types of clinical devices come in a number of different formats, each suitable for a particular technique or specialized application. RAPID TEST FORMATS
| Strip / Dipstick Test | Cassette / Card Test | Midstream Test | Panel Test |
PRODUCT
LIST |
Fertility
Tests (Pregnancy and Ovulation) |
Category |
Product
Name |
Format |
Specimen |
Sensitivity |
Kit
Size |
Packaging |
qualification |
W1 |
hCG
Pregnancy Test |
Strip,
Cassette, Midstream,
MidstreamI,
MidstreamII,
MidstreamIII, |
Urine |
25
mIU/mL |
400
Tests
100 Tests
100 Tests |
Bag |
CE
Approval
FDA Approval |
100
Tests
25 Tests |
Box |
W1(20mIU) |
hCG
Pregnancy Test |
Strip,
Cassette, Midstream,
MidstreamI |
Urine |
20
mIU/mL |
400
Tests
100 Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W1(10mIU) |
hCG
Pregnancy Test |
Strip,
Cassette, Midstream,
MidstreamI |
Urine |
10
mIU/mL |
400
Tests
100 Tests
100 Tests |
Bag
|
CE
Approval |
100
Tests
25 Tests |
Box |
W2 |
LH
Ovulation Test |
Strip,
Cassette, Midstream |
Urine |
25
mIU/mL |
400
Tests
100 Tests
100 Tests |
Bag |
CE
Approval
FDA Approval |
100
Tests
25 Tests |
Box |
Infectious
Disease Tests (Hepatitis HBV, HCV, HIV) |
Category |
Product
Name |
Format |
Specimen |
Sensitivity |
Kit
Size |
Packaging |
|
W3 |
HBsAg
Hepatitis B Surface Antigen Test |
Strip,
Cassette, |
Serum/Plasma
Whole Blood/
Serum/Plasma |
1
ng/mL |
400
Tests
100 Tests |
Bag |
|
|
Box |
W3 |
Combo
Test of Hepatitis B Virus |
Panel |
Serum/Plasma |
Custom |
100
Tests |
Bag |
|
25
Tests |
Box |
W4 |
HBsAb
Hepatitis B Surface Antibody Test |
Strip,
Cassette |
Serum/Plasma
Whole Blood/
Serum/Plasma |
10mIU/mL |
400
Tests
100 Tests |
Bag |
|
|
Box |
W5 |
HCV
Hepatitis C Virus Test |
Strip,
Cassette |
Serum/Plasma
Whole Blood/
Serum/Plasma |
Custom |
400
Tests
100 Tests |
Bag |
|
100
Tests
25 Tests |
Box |
W6 |
HIV
1+2 Human Immunodeficiency Virus 1/2 Test |
Cassette |
Whole
Blood/
Serum/Plasma |
Custom |
100
Tests |
Bag |
|
25
Tests |
Box |
Drugs
of Abuse Tests (Individual) |
Category |
Product
Name |
Format |
Specimen |
Sensitivity |
Kit
Size |
Packaging |
|
W7 |
AMP
Amphetamine Test |
Strip,
Cassette |
Urine |
1000
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W8 |
BAR
Barbiturates Test |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W9 |
BZO
Benzodiazepines Test |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W10 |
COC
CocaineTest |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W11
|
mAMP/
MET Methamphetamine Test
|
Strip,
Cassette
|
Urine
|
1000
ng/mL
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W12 |
MDMA
Ecstasy Test |
Strip,
Cassette |
Urine |
500
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W13
|
MDMA
Morphine Test
|
Strip,
Cassette
|
Urine
|
500
ng/mL
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W14 |
MOP
Morphine Test |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W15 |
MTD
Methadone Test |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W16 |
OPI
Opiate Test |
Strip,
Cassette |
Urine |
300
ng/mL |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
W17
|
PCP
Phencyclidine Test
|
Strip,
Cassette
|
Urine
|
25
ng/mL
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W18
|
TCA
Tricyclic Antidepressants Test
|
Strip,
Cassette
|
Urine
|
Custom
|
400
Tests
100 Tests
|
Bag
|
CE
Approval |
100
Tests
25 Tests
|
Box
|
W19
|
THC
Marijuana Test
|
Strip,
Cassette
|
Urine
|
50
ng/mL
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
Drugs
of Abuse Tests (Multi-Test Panels) |
Category |
Product
Name |
Format |
Specimen |
Sensitivity |
Kit
Size |
Packaging |
|
W2002-P
|
Multi-Drug
2 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2003-P
|
Multi-Drug
3 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2004-P
|
Multi-Drug
4 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2005-P
|
Multi-Drug
5 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2006-P
|
Multi-Drug
6 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2007-P
|
Multi-Drug
7 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2008-P
|
Multi-Drug
8 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2009-P
|
Multi-Drug
9 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
W2010-P
|
Multi-Drug
10 Test
|
Panel
|
Urine
|
Variable
|
100
Tests
|
Bag
|
CE
Approval |
15
Tests |
Box |
Tumor
Marker Tests |
Category
|
Product
Name
|
Format
|
Specimen
|
Sensitivity
|
Kit
Size
|
Packaging
|
|
W30
|
FOB
Fecal Occult Blood Test
|
Strip,
Cassette
|
Feces
|
Custom
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W31
|
PSA
Semi-Quantitative Prostate Specific Antigen Test
|
Strip,
Cassette
|
Whole
Blood/
Serum/Plasma
|
Custom
|
400
Tests
100 Tests
|
Bag
|
CE
Approval |
100
Tests
25 Tests
|
Box
|
W32
|
AFP
Semi-Quantitative Alfa Feto Protein Test
|
Strip,
Cassette
|
Whole
Blood/
Serum/Plasma
|
Custom
|
400
Tests
100 Tests |
Bag |
CE
Approval |
|
Box |
W33 |
CEA Semi-Quantitative
Carcinoma Embryonic Antigen |
Strip,
Cassette |
Whole
Blood/
Serum/Plasma |
Custom |
400
Tests
100 Tests |
Bag |
CE
Approval |
100
Tests
25 Tests |
Box |
STD
(Sexually Transmitted Diseases) Tests |
Category
|
Product
Name
|
Format
|
Specimen
|
Sensitivity
|
Kit
Size
|
Packaging
|
|
W34
|
Syphilis
Test
|
Strip,
Cassette
|
Serum/Plasma
|
Custom
|
400
Tests
100 Tests |
Bag |
|
|
Box |
W35
|
Chlamydia
Test
|
Cassette
|
Swab/Urine
|
Custom
|
100
Tests
|
Bag
|
|
25
Tests |
Box |
W36 |
Gonorrhea
Test |
Cassette
|
Swab/Urine
|
Custom
|
100
Tests
|
Bag
|
|
25
Tests
|
Box
|
Other
Products |
Category |
Product
Name |
Format |
Specimen |
Sensitivity |
Kit
Size |
Packaging |
|
W37 |
Malaria
Test |
Cassette |
Whole
Blood |
Custom |
100
Tests |
Bag |
|
25
Tests |
Box |
W38 |
H.Pylori
test |
Cassette |
Serum/Plasma |
Custom |
100
Tests |
Bag |
|
25
Tests |
Box |
W39 |
StrepA |
Cassette |
Throat
swab |
Custom |
100 Tests
|
Bag |
FDA
Approval |
25
Tests |
Box |
W46 |
Troponinl
Test |
Cassette |
Serum/Plasma |
Custom |
100
Tests |
Bag |
|
25
Tests |
Box |
Other Immune Products | Cat. No. | Product Name | Kit Size | Method | Packaging | W44-C | ds-DNA | 20 Test | Colloidal Gold | Box | W45-C | ds-DNA | 40 Test | Colloidal Gold | Box | WI001 | ANA | 50 Test | IFA | Box | WI012 | Hep-2 | 10 Test | IFA | Box | WE002 | ENA | 40 Test | Western Blotting | Box | WE003 | ENA-7 | 20 Test | Blotting | Box |
|