CLIA WAIVED TESTS

AND

RAPID TESTING

Hemoglobin A1c (CLIA Waived)

Bayer DCA 2000+ Analyzer

• Cat. No. 5031-C
  

• For Easy and Accurate In-Office Diabetes Management
  

• Accurate Results in just 6 minutes
  

• Requires only 1 ul of blood
  

• CV of 2.6% detects smallest change in glycemic control
  

• NGSP-certified method, as recommended by the ADA
  

• Correlation study shows 99% agreement with HPLC method
  

• Microalbumin/Creatinine Results in just 7 minutes using 40 ul Urine
  

• Automatic calculation of Albumin:Creatinine Ratio
  

DCA 2000 HbA1c Reagent Kit

• Cat. No. 5035-B                                 Size: 10/pkg
  

DCA 2000 Microalbumin/Creatinine Reagent Kit

• Cat. No. 6011-0                                 Size: 10 tests/kit
  

DCA 2000 Microalbumin/Creatinine Low/High Control Kit

• Cat. No. 6012-0                                  Size: 4 vials/kit
  

DCA 2000 HbA1c Normal/Abnormal Control Combination Kit

• Cat. No. 5068-0                                 Size: 4 vials/kit
  

Metrika A1c NOW (CLIA Waived)

Metrika A1c NOW

• Cat. No. 430-9913 Size: 10/box
  

• Fast...results in only 8 minutes
  

• Easy...Rapid Test, Finger Stick and 3 Simple Steps
  

• Accurate...NGSP certified and factory calibrated
  

• Cost Effective...requires no test strips or capital equipment
  

Fecal Occult Blood (CLIA Waived)

Hemocult

Hemocult Single Slide Test

• Cat. No. U301-0                                  Size: 100 Test
  

Hemocult II Multiple Slides for Serial Testing (34 x 3)

• Cat. No. U301-0                                  Size: 102 Test
  

Hemocult II Dispensapak for Patient Use (100 x 3)

• Cat. No. U301-2                                  Size: 300 Test
  

Hemocult II Dispensapak Plus for Patient Use

• Cat. No. U301-3                                  Size: 40 kits
  

Hemocult Tape

• Cat. No. U301-4                                  Size: 2 kits
  

Hemocult Developer

• Cat. No. U301-5                                  Size: 20 x 15 mL
  

Hemocult Mailing Pouches (USPS, 39CFR, Part 111)

• Cat. No. U301-6                                 Size: 100/pkg
  

Hemocult Sensa Dispensapak Plus

• Cat. No. U302-0                                 Size: 40 kits/pkg
  

Hemocult Sensa Single Slides

• Cat. No. U302-1                                        Size: 100/pkg
  

Hemocult Sensa Single Slides (Bulk Pack)

• Cat. No. U302-2                                        Size: 10 x 100/box
  

Hemocult Sensa Developer

• Cat. No. U302-3                                        Size: 20 x 15 mL
  

HemaScreen

HemaScreen (FOB) Kit Complete

• Cat. No. HS-100                                        Size: 100 Test
  

HemaScreen (FOB) Kit Complete with Mail Envelopes

• Cat. No. HS50PP                                      Size: 50 Test
  

HemaScreen (FOB) Kit Complete

• Cat. No. HSTAT5                                      Size: 50 Test
  

Immunoassay Fecal Occult Blood (iFOBT)

Clearview Ultra FOBT (CLIA Waived)

• One Step Lateral Flow Method
  

• Overall accuracy of 98.9%, specific for human hemoglobin
  

• Sensitivity: 50 ug hHb/g feces
  

• Room temperature storage
  

Clearview Ultra FOB Test Kit with Collection Papers

• Cat. No. 8109KCV
  

• Size: 50 test strips in cannister, 50 sample collection bottles, 50 collection papers, 1 directional insert
  

Clearview Ultra FOB Test Kit

• Cat. No. 8106KCV
  

• Size: 50 test strips in cannister, 1 directional insert
  

Clearview Ultra FOB Test Kit

• Cat. No. 8105KCV
  

• Size: 50 sample collection bottles
  

Clearview Ultra FOB Test Personal Patient Kit

• Cat. No. 8101KCV
  

• Size: 20 sample collection bottles, 20 sample collection papers, 20 sample mailers
  

Clearview Ultra FOB Test Controls

• Cat. No. 8102KCV
  

• Size: One positive and one negative control
  

Quidel (QuickVue) iFOBT Test

iFOBT Test Kit

• Cat. No. 20194 Size: 20 tests/kit
  

• Kit Includes: 20 individually wrapped test cassettes, package inser, procedure card, 20 specimen collection and return kits consisting of: specimen collection tube, patient ID label, specimen collection paper with adhesive, specimen pouch, absorbent sleeve, return mail pouch, patient instructions
  

Sedimentation Rate (ESR) (CLIA Waived)

Wintrobe

Tubes, Disposable, Single Calibration

• Cat. No. G370-0                                        Size: 100/pkg
  

Tubes, Disposable, Single Calibration

• Cat. No. G370-1                                        Size: 1000/case
  

Tubes, Disposable, Full Calibration-No Rack

• Cat. No. G371-0                                        Size: 100/pkg
  

Tubes, Disposable, Full Calibration-No Rack

• Cat. No. G371-1                                        Size: 1000/case
  

Tubes, Disposable, Full Calibration-With Rack

• Cat. No. G372-0                                        Size: 100/pkg
  

Tubes, Disposable, Full Calibration-With Rack

• Cat. No. G372-1                                        Size: 1000/case
  

Tubes, Disposable, Cotton-Plugged, Self-Zeroing

• Cat. No. G375-0                                        Size: 100/pkg
  

Tubes, Disposable, Cotton-Plugged, Self-Zeroing

• Cat. No. G375-1                                        Size: 1000/case
  

ESR Racks, 10-place for G375

• Cat. No. Chase 15N                                  Size: each
  

Sedi-Pet, 4 ml Capacity, 6 in

• Cat. No. P251-0                                        Size: 500/box
  

Westergren

Sedigren Auto-Zero Westergren ESR System

• Cat. No. G377-1                                        Size: 100 Test/kit
  

• Cat. No. G377-2                                        Size: 250 Test/kit
  

• Cat. No. G377-3                                        Size: 1000 Test/kit
  

• Cat. No. G377-4                                        Rack for up to 10 tests
  

Sedi-Rate™ Autozero Westergren ESR System (Pipettes & Citrate Vials)

• Cat. No. G401-0                                        Size: 600 Test Kit
  

• Cat. No. G401-1                                        Size: 100 Test Kit
  

• Cat. No. G401-2                                        Size: 200 Test Kit
  

• Cat. No. G401-3                                        Sedi-Rate Rack, 10-place
  

Chase Universal Self-Zeroing ESR by Westergren

Tubes for Chase Universal ESR Rack

• Cat. No. G380-0                                        Size: 100/pkg
  

Tubes for Chase Universal ESR Rack

• Cat. No. G380-1                                        Size: 1000/case
  

Dispette II ESR System

Dispette II

• Cat. No. G400-0   Size: 100/pack)
  

• Cat. No. G400-cs Size: 1000/cs)
  

Liquichek Sedimentation Rate Controls (540-Day Shelf Life)

• Cat. No. 514          Level I                          Size: 4 x 9 mL
  

• Cat. No. 515          Level II                         Size: 4 x 9 mL
  

• Cat. No. 514x        Bi-Level                        Size: 2 x 9 mL
  

SEDRate Plus Whole Blood ESR Control (195-Day Shelf Life)

• Cat. No.SR002       Dual Pak (Level I & II)           Size: 4 of each level (8 x 8.5 mL)
  

• Cat. No. SR002X    Dual Pak (Level I & II)            Size: 2 of each level (4 x 8.5 mL)
  

• Cat. No. SR003      Dual Pak (Level I & II)    Size: 6 of each level (12 x 4.5 mL)
  

Infectious Disease Testing

Helicobacter Pylori (H. Pylori)

Quidel

H. Pylori, Quidel® QuickVue (WAIVED) (Whole Blood)

• Cat. No. S300-0                                         Size: 10 Test/kit
  

• Cat. No. S301-0                                                 Size: 30 Test/kit
  

H. Pylori, Quidel® QuickVue (Moderate Complexity) (Serum)

• Cat. No. S302-0                                                 Size: 10 Test/kit
  

• Cat. No. S303-0                                                 Size: 30 Test/kit
  

Clearview (Inverness/Wampole)

H. Pylori, Clearview™ (Whole Blood/Serum/Plasma)

• Cat. No. 6706KCV                                             Size: 30 Test/kit
  

• CLIA Complexity: MODERATE (serum/plasma) WAIVED (wh blood)
  

• Simple, Rapid Immunoassay
  

• Detects H. Pylori in Serum/Plasma/Whole Blood
  

• Accurate test results within 5 minutes
  

• Built In Test Control
  

Strep A

Strep A, Quidel® QuickVue In Line, 1-Step

• Cat. No. S191-1                                                 Size: 25 Test/kit
  

• CLIA Complexity: WAIVED
  

• CPT Code: 87880QW
  

Strep A, Clearview™ Exact (1-minute test)

• Cat. No.6210KCV                                                 Size: 30 Test/kit
  

• CLIA Complexity: WAIVED
  

• Simple Rapid Test for Detection of Group A Streptococcus
  

• 99% Specificity
  

• 95.1% Sensitivity
  

• 97.7% Overall Accuracy
  

• Test Completed in about 7 Minutes
  

Strep A, Trueview™

• Cat. No.104-8802                                                Size: 25 Test/kit
  

• CLIA Complexity: WAIVED
  

• Simple Rapid Test for Detection of Group A Streptococcus
  

• 99% Specificity
  

• 95.1% Sensitivity
  

• 97.7% Overall Accuracy
  

• Test Completed in about 5 Minutes
  

• Includes positive and negative controls
  

Dacron Polyester Tipped Applicators, Sterile, 1/Envelope

• Cat. No. L111-0                                                  Size: 100/box
  

Influenza A/B

Flu A/B Kit (Inverness/Wampole/Binax) (Waived)

• Cat. No. 416-110 Size: 10 tests/kit
  

• Kit Contains: test devices, transfer pipettes, positive control swab, negative control swab, elution solution, NP swabs
  

• Specimen: Nasal Swab or Nasal Wash/Nasal Aspirate
  

• Approximate Test Time: 15 minutes
  

Influenza A/B Kit, Quidel® QuickVue

• Cat. No. Q-00317                                              Size: 25 Test/kit
  

• CLIA Complexity: Waived
  

• CPT Code 87804QW
  

• Specimen: Nasal Swab or Nasal Wash/Nasal Aspirate
  

• Approximate Test Time: 10-11 minutes
  

Chlamydia

Chlamydia Test Kit, Quidel® QuickVue

• Cat. No. S-B006                                        Size: 25 Test/kit
  

• CLIA Complexity: Moderate
  

• 92% Sensitivity
  

• 98.6% Specificity
  

• Test Specimen using Endocervical swab or cytology brush
  

• Test Completed in about 12 Minutes
  

• CPT Code: 87449
  

Clearview™ Chlamydia Test

• Cat. No.  135301 Size: 20 Test/kit
  

• CLIA Complexity: Moderate
  

• 87% Sensitivity
  

• 98.8% Specificity
  

• Test Specimen using Endocervical swab or cytology brush
  

• Test Completed in about 12 Minutes
  

• CPT Code: 87449
  

Clearview™ Female Collection Kit

• Cat. No. 135315 Size: 20 test
  

• Sterile Dacron Swabs
  

Clearview™ Chlamydia Workstation

• Cat. No. 130035   Size: each
  

• 80-82 C Heating Block w5 temp controlled wells
  

• 5-Position cooling rach
  

G. Vaginalis

Quidel® QuickVue Advance G. Vaginalis

• Cat. No. 20145                                          Size: 25 Test/kit
  

• CLIA Complexity: Moderate
  

• CPT Code: 82657
  

• Sensitivity
  

• Specificity
  

• Test Specimen using Endocervical swab or cytology brush
  

• Test Completed in about 5 Minutes
  

Quick Vue Advance pH and Amines Test

• Cat. No. 20146                                                  Size: 25 Test/kit
  

• CLIA Complexity: Waived
  

• CPT Code: 83986QW (pH)
  

• CPT Code: 82120QW (Amines)
  

• Sensitivity
  

• Specificity
  

• Test Specimen using Endocervical swab or cytology brush
  

• Test Completed in about 5 Minutes
  

Herpes Simplex Type 2

• Cat. No. 3000-28001   Size: 20 tests/kit
  

• CLIA Complexity: Moderate (whole blood/serum)
  

• CPT Code: 86696
  

• 80% of recurring genital herpes due to HSV type 2
  

• Glycoprotein G (gG-2) based test
  

• Test performed in under 5 minutes
  

• Test simple to interpret (2 spots = positive, 1 spot = negative
  

Mononucleosis

Clearview™ Mono-EIA Test

• Cat. No. S195-0                                                 Size: 30 Test/kit
  

• CLIA Complexity: WAIVED
  

• Simple, Rapid Test for the Detection of IgM Ab to Infectious Mono
  

• Specimen: Whole Blood  (Finger Stick)
  

• 98.6% Sensitivity
  

• 98.8% Specificity
  

• Test Completed in about 5 Minutes
  

• CPT Code: 86308 QW
  

OSOM Mono Test

• Cat. No. WD145                                                Size: 25 Test/kit
  

• CLIA Complexity: Waived (whole blood); Moderate (serum or plasma)
  

• Simple, Rapid Test using immunochromatigraphic dipstick technology
  

• Specimen: Whole Blood, Serum or Plasma
  

• 100% Sensitivity
  

• >99% Specificity
  

• Test Completed in about 5 Minutes
  

• CPT Code: 86308QW (whole blood) or 86308 for serum or plasma
  

Pregnancy/Fertility Tests

Pregnancy Test

• Cat. No. S185-S                                                Size: 25 Test/kit
  

• CLIA Complexity: WAIVED (Urine) or Moderate (Serum)
  

• Cassette may be used with Urine or Serum
  

• Poly/Monoclonal Ab Combination ensures Specificity & Sensitivity
  

• Positive results develop within 3 minutes
  

• Permits early detection (25 mIU/mL)
  

• Highly visible results for ease of interpretation
  

• CPT Code: 81025 (urine) or 84703 QW (serum)
  

Pregnancy Test

• Cat. No. S187-0                                                 Size: 20 Test/kit
  

• CLIA Complexity: WAIVED (Urine)
  

• Cassette may be used with Urine
  

• Poly/Monoclonal Ab Combination ensures Specificity & Sensitivity
  

• Positive results develop within 3 minutes
  

• Permits early detection (25 mIU/mL)
  

• Highly visible results for ease of interpretation
  

• CPT Code: 81025 (urine)
  

Clearview™ One-Step Pregnancy Test

• Cat. No. 6008KCV                                             Size: 30 Test/kit
  

• High Sensitivity
  

• CLIA Complexity: WAIVED
  

• Cassette may be used with Urine
  

• Colloidal Gold/Monoclonal Ab Combination
  

• Positive results develop as soon as 1 minute
  

• Permits early detection (20 mIU/mL)
  

• Highly visible results for ease of interpretation
  

• CPT Code: 81025 (urine)
  

Clearview™One-Step Pregnancy Test (Combo) with Reference Line

• Cat. No. 6028KCV                                             Size: 30 Test/kit
  

• High Sensitivity
  

• CLIA Complexity: WAIVED (Urine) or Moderate (Serum)
  

• Cassette may be used with Urine or Serum
  

• 3 Line Combo has additional Reference Line Set @ 25 mIU/ml
  

• Colloidal Gold/Monoclonal Ab Combination
  

• Positive results develop as soon as 1 minute
  

• Permits early detection (20 mIU/mL for Urine or 10 mIU/mL for Serum)
  

• Highly visible results for ease of interpretation
  

• CPT Code: 84703QW (urine) or 84703 (serum)
  

Clearview™ hCG Test Strips

• Cat. No. 6007KCV                                             Size: 50 Test/kit
  

• CLIA Complexity: WAIVED
  

• High Sensitivity
  

• Test Stick may be used with Urine only
  

• Colloidal Gold/Monoclonal Ab Combination
  

• Positive results develop as soon as 1 minute
  

• Permits early detection (20 mIU/mL)
  

• Highly visible results for ease of interpretation
  

• CPT Code: 84703QW (urine)
  

Clearview™ hCG Controls

• Cat. No. 6009KCV      Size: 2 vials (1 positive and 1 negative)
  

Ovulation Test

Sterling LH Ovulation Test

• Cat. No. S190-0                                                 Size: 25 Test/kit
  

• CLIA Complexity: WAIVED
  

• Rapid One-Step Urine Test
  

• Qualitative Detection of LH at 35 mIU/ml or higher
  

• Clear, Accurate, Easy to Read Result in about 3 Minutes
  

• Room Temperature Storage with 24 Month Shelf-Life
  

• CPT Code: 83002 QW
  

Menopause Test

Sterling FSH Menopause Test

• Cat. No. S104-0                                                 Size: 25 Test/kit
  

• CLIA Complexity: WAIVED
  

• Test performed using First Morning Urine Specimen
  

• Two Site Sandwich Immunoassay for FSH ensures Specificity and Sensitivity
  

• Positive results develop within 5 minutes
  

• Permits detection at 25 mIU/mL (FSH)
  

• Highly visible results for ease of interpretation
  

• Test requires repeat in 5-7 days for confirmation and physician consultation
  

• CPT Code: 83001 QW
  

Lyme Disease

Lyme Disease, PreVue™ B. burgdorferi

• Cat. No. 63220                                                  Size: 20 Test/kit
  

• CLIA Complexity: WAIVED
  

• Qualitative detection of IgG/IgM Antibodies using Recombinant Antigens
  

• Results develop within 20 minutes
  

• CPT Code: 86618 QW
  

Rotavirus

SureVue Rotavirus Test

• Cat. No. SA069111     Size: 25 test/kit
  

• CLIA Complexity: Moderate
  

Rotavirus Control

• Cat. No. SA069101     Size: 2 x 1 mL
  

Immunocard STAT! Rotavirus Test

• Cat. No. 14-910-172    Size: 30 tests/kit
  

Coaguchek™ S and ITC ProTime (See Coagulation Section)

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