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CLIAwaived.com
11578 Sorrento Valley Road
Suite 25/26
San Diego, CA 92121
858-481-5031 tel
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Toll Free 1-888-882-7739
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Womens Health

 

OSOM hCG Urine Test
GZM-101
(50 tests)
For the qualitative determination of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy.
$53.95

 

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OSOM hCG Card Pregnancy Test
GZM-102
(25 tests)
A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine as an aid in the early determination of pregnancy.
$32.95

 

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OSOM hCG Combo Test
GZM-124
(25 tests)
A rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy.
$43.75

 

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hCG urine control
GZM-134
(2 x 5mL) -Select NDA Shipping
The OSOM hCG Urine Control Set is intended for in vitro diagnostic use in quality control testing with OSOM hCG-Urine, OSOM Card Pregnancy and the OSOM hCG Combo Test.

The OSOM hCG Urine Control Set provides 1 Negative Control and 1 Positive Control in saline. The Positive Control contains purified hCG; the Negative Control is free of detectable hCG. When used for quality control in OSOM hCG-Urine, OSOM Card Pregnancy and the OSOM hCG Combo Test, the Controls are useful as an aid in verifying test and operator performance.

STORAGE
The OSOM hCG Urine Control Set must be stored refrigerated (2°-8°C; 36°- 46°F).
• Do not freeze
• Tightly seal the vials after use to prevent evaporation.
• Store vials upright to prevent spills and leakage


$24.95

 

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Osom Serum Control Set
GZM-138
(2 x 5mL)- Select NDA Shipping
The OSOM hCG Serum Control Set is intended for in vitro diagnostic use in quality control testing with the OSOM hCG Combo Test.

The OSOM hCG Serum Control Set provides a Negative Control and a Positive Control in horse serum. The Positive Control contains purified hCG; the Negative Control is free of detectable hCG. When used for quality control in the OSOM hCG Combo Test, the Controls are useful as an aid in verifying test and operator performance.

STORAGE
The OSOM hCG Serum Control Set must be stored refrigerated (2-8C; 36- 46F).
 Do not freeze
 Tightly seal the vials after use to prevent evaporation.
 Store vials upright to prevent spills and leakage.

$30.95

 

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Strep A (52 tests to kit)
GZM-141
(50 tests + 2 free)
A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.
$74.95

 

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OSOM Mono Test Kit (27 tests)
GZM-145
(25 + 2 tests)
For the qualitative detection of infectious mononucleosis heterophilic antibodies in serum, plasma or whole blood.
$78.95

 

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OSOM Ultra Strep A Test
GZM-147
(25 Tests) +2 Extra for QC/QA testing
Genzyme Ultra Instant Strep Testing, color immunochromatographic assay using Dual Label Technology (DLT). DLT uses antibody labeled color particles coated at two separate locations which allows for greater sensitivity than the conventional single label technology without sacrificing specificity. FDA Cleared and CLIA Waived. (FDA 510K#: K992658) (NOT APPROVED FOR HOME USE-MEDICAL PROFESSIONALS ONLY)
$65.95

 

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OSOM Ultra Strep (27 tests)
GZM-149
(50 tests + 2 free)
A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.
$114.95

 

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OSOM H Pylori Test
GZM-175
(25 tests)
For the qualitative detection of H. pylori antibodies in serum, plasma or whole blood as an aid in the diagnosis of H. pylori infection.
$142.95

 

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H. pylori Control Set
GZM-176
(2 x 2mL)
The H. pylori Control Set is intended for in vitro diagnostic use as an unassayed quality control for the determination of Immunoglobulin G (IgG) antibodies to Helicobacter pylori. This product should only be used to estimate the precision and monitor the performance of the OSOM® H. pylori Test. The set contains external positive and negative serum controls for qualitative use.
SUMMARY AND PRINCIPLE
The H. pylori Control Set uses a specially formulated matrix to provide satisfactory results when used with the OSOM® H. pylori Test. Although this product does not have assigned values, positive and negative controls are provided to facilitate monitoring in the expected clinical range.

$35.95

 

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OSOM Trichomonas Test
GZM-181
A rapid test for the detection of Trichomonas vaginalis

Trichomonas Educational Brochure- U.S.Trich Edu Brochure

Trichmonas Educational Brochure-EU



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OSOM Trichomonas Positive Control Kit
GZM-182
(25 Tests)
INTENDED USE
The OSOM® Trichomonas Positive Control Kit is intended for in vitro diagnostic use in quality control testing with the OSOM Trichomonas Rapid Test.
SUMMARY
The OSOM Trichomonas Positive Control Kit provides swabs coated with a dried mixture containing Trichomonas antigens. The level of Trichomonas antigen applied to the swab is sufficient to provide a positive result when used with the OSOM Trichomonas Rapid Test. Sterile rayon swabs supplied in the Trichomonas Rapid Test kit are free of Trichomonas antigens and can be used as negative controls. When used for quality control in the OSOM Trichomonas Rapid Test,

STORAGE
The OSOM Trichomonas Positive Control Kit must be stored at room temperature (15°-30°C; 59°-86°F). Keep Tightly close

$29.95

 

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OSOM BVBLUE Test
GZM-183
(25 tests)
Detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. FDA Cleared and CLIA waived. (FDA 510K#: K050755)

(PLEASE SELECT NEXT DAY AIR SHIPPING FOR PRODUCT STABILITY)

$229.95

 

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BVBlue Controls – refrigerated
GZM-184
(2 x 5mL)
INTENDED USE:
The OSOM® BVBLUE
® Control Kit is intended for in vitro diagnostic use
with the OSOM BVBLUE Test as unassayed control material to monitor
test performance.
SUMMARY:
The controls are for use with the OSOM BVBLUE Test. The OSOM
BVBLUE Positive Control is a solution of sialidase that is supplied in a
dropper bottle and will produce a green or blue color when used with the
test. The BVBLUE Negative Control is a solution of sialidase at a level
below the test’s limit of detection. It is supplied in a dropper bottle and will
produce a yellow color when used with the test. These controls may be
used to confirm the integrity of the reagents in the test vessel.

$19.95

 

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OSOM A/B Flu test (27 tests)
GZM-190
(25 tests + 2 Free)
An immunochromatographic assay intended for the qualitative detection of Influenza A and Influenza B viral nucleoprotein antigens from nasal swab specimens. FDA Cleared for Professional Use. Not CLIA waived

Features and Benefits

•Differentiates between Influenza
A and B
•Easy-to-read, 3 distinct lines
•2 extra test sticks included for external QC testing
•Less than 1 minute hands-on time, results in 10 minutes
•CPT Code: Influenza A 87804
Influenza B 87804-59


$249.95

 

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AlcoScreen .02% Test
CHEM-56288
(24 test strips)
Alcohol: Rapid, highly sensitive method to detect the presence of alcohol in saliva and provide a relative blood alcohol concentration. 510K Cleared and CLIA waiived

Alcohol testing is recommended by the U.S. preventative service task force on all annual visits.

An annual visit provides an excellent opportunity to counsel patients about maintaining a healthy lifestyle and minimizing health risks. This annual visit is an opportunity to focus on disease prevention and health promotion. Patient services should include screening for tobacco use, alcohol/drug misuse, intimate partner violence, and depression. High-risk sexually active women should be counseled on reducing the risk of sexually transmitted infections, and screened for STD/STIs. All women should be screened for human immunodeficiency virus.

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Cardiochek Analyzer + 1 Smartbundle (CHEK-2729)
CHEK-2700
1 analyzer + 15 lipids and 15 glucose
Recognizing the linkage between heart attack, stroke, and diabetes, the CardioChek® Plus analyzer provides rapid on-site lipid panel plus glucose screening to help identify at-risk individuals. The capability to deliver both results in as little as 90 seconds enables healthcare professionals to improve their throughput, which is particularly important in today’s health promotion/screening environment.

Promo bundle include 1 analyzer and 1 smart bundle. Each smart bundle includes 15 lipid tests, 15 e glucose tests. This product is 510K Cleared and CLIA waived.

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HIV 1/2 STAT-PAK® Assay
CHEMBIO-60-9505-1
(20 tests)
A rapid, qualitative assay for the detection of antibodies to HIV-1 and
HIV-2 in fingerstick whole blood, venous whole blood, serum, or plasma.

$159.95

 

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Thyrochek Rapid Test
THYROCHEK-120-A-KIT
(20 tests)- controls sold seperately
Thyroid (TSH) Hormone Testing Kits, . ThyroChek tests for elevated thyroid stimulating hormone (TSH) in whole blood. ThyroChek requires one drop of blood from a finger stick or venous draw. Results in 10 min. Controls NOT included. CPT code: 84443, Reimbursement $23.40. 510K Cleared and CLIA Waived. (FDA 510K#: K990658)
$159.95

 

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NicCheck I Test Strips
MA-500-01-KIT
(50 per box)
NicCheck I Test Strips may be used to detect nicotine and/or its metabolites in urine as an aid in indicating the smoking status of the individual and in planning appropriate treatment. The test will also aid in the identification of a smoker as a low or high nicotine consumer. The NicCheck I test is 510K Cleared and CLIA waived. Individuals, such as physicians, nurses, pharma-cists, medical technologists, and paramedical personnel may perform the test. NOT FOR HOME USE OR SELF TESTING. (FDA 510K#: K963733) (PLEASE SELECT AIR SHIPPING FOR PRODUCT STABILITY)

CPT: G0478 and 80305QW

$243.15

 

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CLIAwaived,Inc 14 panel RDTC cup
CLIA-14 RDTC
(25 cups)
The CLIAwaived, Inc. 14 panel Rapid Drug Test Cup is the first-ever 510Kcleared and CLIA-waived 14-panel drug test cup with integrated adulteration testing and Buprenorhine. Exclusively marketed by CLIAwaived.com, it features a simple design for simultaneous evaluation and detection of 14 drugs of abuse in urine. New lower cut-offs makes this cup ideal for pain management and addiction screening. Tests for: THC 50, BUPG 10, COC 150, OPI 300, AMP 500, mAMP 500, PCP 25, BAR 300, BZD 300, MTD 300, MDMA 500, OXY 100, TCA 1000, PPX 300. Cup includes adulterant testing for creatinine, nitrite, pH, bleach and SG. Activate cup by turning once. Read results at 5 minutes. In-stock; ships immediately.
$137.50

 

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