No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | MRG | System, Test, Vitamin D | FastPack® IP Vitamin D Kit Complete | |
2 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | JHI | Visual, Pregnancy Hcg, Prescription Use | FastPack® IP hCG Kit (30) | |
3 | 10816467020010 | TPSA Immunoassay | 25000001 | 50 Test Non-Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® Total PSA Kit (50) | |
4 | 00816467020372 | Pro System | 08000067, 08000067-R, 08000067-X | RoHS Compliant 7-chamber FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® Pro System |
5 | 00816467020075 | TPSA Verifier | 25000017 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - PSA | |
6 | 20816467020086 | TSH Immunoassay | 25000042 | 30 Test Ported TSH Immunoassay Kit | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FastPack® IP TSH Kit (30) | |
7 | 00816467020167 | PSA Controls | 25000003 | Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Control Kit - PSA |
8 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | CEC | Radioimmunoassay, Free Thyroxine | FastPack® IP Free T4 Kit (30) | |
9 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
10 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
11 | 20816467020017 | TPSA Immunoassay | 25000040 | 30 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (30) | |
12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
13 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
14 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
15 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | QKO | Reagent, Coronavirus Serological | FastPack SARS-CoV-2 IgG | |
16 | 00816467020020 | TPSA Cal | 25000002 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - PSA | |
17 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System | |
18 | 00816467020099 | TSH Cal | 25000024 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – TSH | |
19 | 00816467020068 | FT4 Cal | 25000016 | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibrator Kit – Free T4 | |
20 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System |
21 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
22 | 00816467020136 | Multi-Analyte Controls | 25000056 | Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | FastPack® Control Kit |
23 | 30816467020014 | TPSA Immunoassay | 25000057 | 90 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (90) | |
24 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG | |
25 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M220P0800633 | P080063 | P080063 | Pro Advantage HCG Urine Cassette 25/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
2 | M220P0800233 | P080023 | P080023 | Pro Advantage Test Strips HCG Urine 100/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
3 | M220P0800213 | P080021 | P080021 | Pro Advantage HCG Urine/Serum Cassette 25/BX | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. |
4 | 08719481720759 | FH-30 | Box with 30 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
5 | 08719481720728 | FK-127s | Box with 25 ovulation teststrips and 5 pregnancy teststrips | iProvèn | MASENA INVEST B.V. | |
6 | 08719481720179 | FK-127-W-HCGtest | HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155 | iProvèn | MASENA INVEST B.V. | |
7 | 08719481720162 | FK-127-HCGtest | HCG strips - pregnancy test strips | iProvèn | MASENA INVEST B.V. | |
8 | 08305901048253 | 1048-25 | The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative det The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. | EZ-hCG Urine Pregnancy Test | BIOMERICA, INC. | |
9 | 06952804801847 | 1.0 | HCG Pregnancy Serum/Urine Combo Test Cassette (20/20) | ASSURE TECH. (HANGZHOU) CO., LTD. | ||
10 | 06952804801830 | 1.0 | hCG Pregnancy Serum/Urine Combo Test Strip(10/20) | ASSURE TECH. (HANGZHOU) CO., LTD. | ||
11 | 06952804801212 | 1.0 | HCG Pregnancy Test Strip | ASSURE TECH. (HANGZHOU) CO., LTD. | ||
12 | 06952804801205 | 1.0 | HCG-C23 | hCG Pregnancy Serum/Urine Combo Test Cassette | ASSURE TECH. (HANGZHOU) CO., LTD. | |
13 | 06952804801090 | 1.0 | hCG Pregnancy Test Cassette | ASSURE TECH. (HANGZHOU) CO., LTD. | ||
14 | 04560189211841 | N/A | AIA-PACK HCG SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
15 | 04560189211834 | N/A | AIA-PACK HCG CALIBRATOR SET | TOSOH CORPORATION | ||
16 | 04560189211360 | N/A | AIA-PACK βHCG Sample Diluting Solution | TOSOH CORPORATION | ||
17 | 04560189211353 | N/A | AIA-PACK βHCG Calibrator Set | TOSOH CORPORATION | ||
18 | 03573026156923 | 30405-01 | VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS VIDAS ® HCG (HCG) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the determination of hCG concentration in human serum or plasma. | VIDAS® HCG | BIOMERIEUX SA | |
19 | 00895160002519 | TF8146 | TF8146 | An in vitro diagnostic test for the determination of beta-Human chorionic gonado An in vitro diagnostic test for the determination of beta-Human chorionic gonadotropin in human whole blood, serum, and plasma. | Fluoro-CheckTM beta-hCG | NANO-DITECH CORPORATION |
20 | 00863545000306 | N/A | dBest | AMERITEK, INC. | ||
21 | 00858022006216 | 8001-50 | 8001-50 | Box of 50 cartridges/tests | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
22 | 00858022006209 | 8001-25 | 8001-25 | Box of 25 cartridges/tests | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
23 | 00858022006193 | 8001-1 | 8001-1 | Box of one test cartridge | AdexusDx hCG Test | NOWDIAGNOSTICS, INC. |
24 | 00857338006330 | F2-CT25C | F2-CT25C | First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
25 | 00857338006224 | F1-CT25U | F1-CT25U | First Sign hCG Pregnancy Urine Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
26 | 00857338006217 | F2-CT25C | F2-CT25C | First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure | First Sign | HEMOSURE INC. |
27 | 00855574005384 | HCG25 | HCG, Immunochromatographic Test | Poly stat | POLYMEDCO, INC. | |
28 | 00853691007205 | 1 | FHC-202 | Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette | Pregnancy (hCG) Urine/Serum Combo Rapid Test Cassette | ACRO BIOTECH INC |
29 | 00850392007275 | BC-1027 | BC-1027 | The BioCheck hCG EIA Test Kit is intended for the quantitative determination of The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. | BioCheck hCG EIA Test Kit | BIOCHECK, INC. |
30 | 00850011007174 | TNR HCGCOMBO | TNR HCGCOMBO | Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,P Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX | Tanner Scientific® | MERCEDES MEDICAL, LLC |
31 | 00846841060700 | HCG(3mm) | ONE STEP HCG URINE PREGNANCY TEST (STRIP) | ChoiceMMed | BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. | |
32 | 00841824102248 | F2-CK04 | F2-CK04 | hCG Pregnancy Urine/Serum Test Cassette (4mm), 25/plain white box | NA | W.H.P.M. INC. |
33 | 00841824102231 | F2-DK04 | F2-DK04 | hCG Pregnancy Urine/Serum Test Strip (4mm), 50 /plain white box | NA | W.H.P.M. INC. |
34 | 00841824102217 | F1-DK04 | F1-DK04 | hCG Pregnancy Urine Test Strip (4 mm ), 50 /plain white box | NA | W.H.P.M. INC. |
35 | 00841824102194 | F1-CK04 | F1-CK04 | WH ACCU hCG Pregnancy Urine Test Cassette (4mm), 40 /colored WH box | WH Accu Test™ | W.H.P.M. INC. |
36 | 00841824102163 | F1-CK04/2 | F1-CK04/2 | hCG Pregnancy Urine Test Cassette (4mm) | NA | W.H.P.M. INC. |
37 | 00841824102033 | F1-C04-100 | F1-C04-100 | hCG Pregnancy Urine Test Cassette (4mm Strip) Sealed in Plain White Pouch, 100pcs/bag | NA | W.H.P.M. INC. |
38 | 00841824101814 | F1-DC04-50 | F1-DC04-50 | hCG Pregnancy Urine Test Dip Card (4mm Strip) Sealed in Plain White Pouch, 50pcs/bag | N/A | W.H.P.M. INC. |
39 | 00840239028181 | RAP-2818 | RAP-2818 | This is a test for the qualitative detection of human Chorionic Gonadotropin (HC This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine. | HCG dipstick Test | DRG INTERNATIONAL INC |
40 | 00840239017833 | EIA-1783 | EIA-1783 | The hCG ELISA is intended for the quantitative determination of human chorionic The hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. | Human Chorionic Gonadotropin (hCG) ELISA | DRG INTERNATIONAL INC |
41 | 00817830020272 | 07RD7002 | 07RD7002 | HCG TEST CARD | RAPID DIAGNOSTICS HCG TEST CARD | RAPID DIAGNOSTICS INC |
42 | 00817830020265 | 07RD7001 | 07RD7001 | HCG TEST STRIP | RAPID DIAGNOSTICS HCG TEST STRIP | RAPID DIAGNOSTICS INC |
43 | 00817763021933 | F1-ST25 | F1-D04 | First Sign hCG Pregnancy Urine Test Strip (4mm); 25Pcs/Box for Hemosure | First Sign® | HEMOSURE INC. |
44 | 00817415021069 | 788525 | 788525 | Pregnancy hCG Test Cassette, 25/Box | Dealmed | DEALMED MEDICAL SUPPLIES LLC |
45 | 00816870020976 | 3325-300 | 3325-300B | Monobind AccuBind hCG Rapid ELISA Kit - 192 Wells | MONOBIND, INC. | |
46 | 00816870020969 | 3325-300 | 3325-300A | Monobind AccuBind hCG Rapid ELISA Kit - 96 Wells | MONOBIND, INC. | |
47 | 00816862022216 | SW1-S | 1-Strip; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
48 | 00816862022179 | HCG-PRE-OTC10 | 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU | Preview | WONDFO USA CO., LTD. | |
49 | 00816862022148 | SW1-C | 1-Panel Cassette; hCG Pregnancy Test SCI | Wondfo | WONDFO USA CO., LTD. | |
50 | 00816862021905 | W1-S3 | 1 Strip; hCG Serum/Urine Test Strip | Wondfo | WONDFO USA CO., LTD. |