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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M7526894410 689-441 PFU Tissue Processing Kit STRADIS HEALTHCARE
2 M752689367R10 689-367R1 PZG Surgical Eye Tray 1 STRADIS HEALTHCARE
3 M752682469NL1 682-469NL VEIN PACK STRADIS
4 M752682264NL10 682-264NL1 OEZ Cardiovascular Procedure Kit STRADIS HEALTHCARE
5 M7526821660R10 682-1660R1 OEZ Cardiovascular Procedure Kit STRADIS HEALTHCARE
6 M7526821300 682-130 CUSTOM SURGICAL KIT OEZ Cardiovascular Procedure Kit 2 STRADIS
7 M752681275R30 681-275 R3 FTN Plastic Surgery And Accessories Kit 1 STRADIS HEALTHCARE
8 M75240902SSS0 40902SSS PWL Oral Surgery Tray STRADIS HEALTHCARE
9 M75240351AKS0 40351AKS PWL Oral Surgery Tray 1 STRADIS HEALTHCARE
10 M752VA2011 VA-201 Lidocaine Supplement Kit Stradis Medical, LLC
11 M752VA1010 VA-101 Dressing Change Tray MCY Wound Dressing Kit 2 Stradis Medical, LLC
12 M752TRNRSS36600 TRNRSS3660 Ready Sharp DEXAMETHASONE LRO General Surgery Tray 2 Stradis Medical, LLC
13 M752TMDCSA10 TMDCSA1 Dressing Change Tray W/CHG MCY Wound Dressing Kit 2 Stradis Medical, LLC
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15 M752TMDCIP30 TMDCIP3 Dressing Change Tray Stradis Medical, LLC
16 M752TMDCIP20 TMDCIP2 Dressing Change Tray Stradis Medical, LLC
17 M752TMDCIP10 TMDCIP1 Dressing Change Tray W/CHG Stradis Medical, LLC
18 M752TMDC10000 TMDC1000 Dressing Change Tray W/CHG MCY Wound Dressing Kit 2 Stradis Medical, LLC
19 M752TMBPMSP10 TMBPMSP1 Biopatch 1450 Kit Stradis Medical, LLC
20 M752TM9538CP0 TM9538CP Port PICC Access Tray Stradis Medical, LLC
21 M752TM7522CP0 TM7522CP Dressing Change Tray W/CHG MCY Wound Dressing Kit 2 Stradis Medical, LLC
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25 M752TM16580 TM1658 Dressing Change Tray MCY Wound Dressing Kit 2 Stradis Medical, LLC
26 M752SR10000 SR-1000 Suture Removal Kit MCZ Suture Removal Kit Stradis Medical, LLC
27 M752RWMDCTSORIS0 RWM-DCT-SOR-IS Dressing Change Tray Stradis Medical, LLC
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29 M752RWMDCTLAMIS0 RWM-DCT-LAM-IS Dressing Change Tray Stradis Medical, LLC
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B512100011 10001 100-01 One Step Pregnancy Test UNIVERSAL MEDITECH INC.
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3 B497542100C1001CA1 C1001C-a Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per box. Market--physician office. R Med Pregnancy Test Cassettes R MEDICAL SUPPLY INC
4 M901W1C0 W1-C W1-C immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG) QuickProfile™ HCG Test Card LUMIQUICK DIAGNOSTICS, INC.
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7 M752682PREG1 682-PREG Pregnancy Kits Stradis Medical, LLC STRADIS MEDICAL, LLC
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10 10817038021214 hCG strip hCG strip UCP HOME Pregnancy Test Strip UCP HOME UCP BIOSCIENCES, INC.
11 10817038021023 UCD-Preg-CLIA UCD-Preg-CLIA Pregnancy Dip Card UCP Home Pregnancy Dip Card UCP BIOSCIENCES, INC.
12 10796918002140 02-2480-2 HCG Midstream Cassette, 2 tests Instant-View HCG Midstream Cassette, 2t ALFA SCIENTIFIC DESIGNS, INC.
13 10722355002887 IDP-25 Home pregnancy test for early results Detector hCG Personal IMMUNOSTICS COMPANY, INC
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16 10722066005146 HCG-1C50 HCG-1C50 Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitat Rapid Response hCG Pregnancy Test Cassettes - 50 tests/ kit are for the qualitative detection of human chorionic gonadotropin in urine. Rapid Response BTNX INC
17 09351337000081 GM-700O Ovulation test GENERATION GUARD PTY LTD
18 09351337000074 GM-700P Pregnancy test GENERATION GUARD PTY LTD
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20 08809408860597 HCGS003E Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the s Surearly™ Pregnancy Test Strip is a strip coated with reagents. One end of the strip is a sample pad for urine dipping, and the control and test regions are located in the middle of the strip. Users immerse the sample pad of the strip into the collected urine and see the test results from the colored lines appeared on the strip. The test results are interpreted by users according to the instructions for use. Surearly™ Pregnancy Test Strip SUGENTECH INC._OSONG BRANCH
21 08809408860191 SU-DR02-CG HCGR001E Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, co Surearly™ Digital Pregnancy Test is a digital test reader with a LCD display, combining with an absorbent tip covered by a plastic cap. The absorbent tip that protrudes from the end of the test reader absorbs and delivers urine to reagents on a RAPID type test strip which is located inside a plastic housing of the device. The test reader is automatically switched on, by removing the power film located at the grip. The absorbent tip is placed in urine stream directly or alternatively immersed into the collected urine. The test reader detects the colored lines and shows the digital test result on the display. Surearly™ Digital Pregnancy Test SUGENTECH INC._OSONG BRANCH
22 08719699634633 FK-127-CO FK-127A contains 50 ovulation test and 20 pregnancy tests. iProven SEVENGROUND TRADING B.V.
23 08719699633254 FMH-139-3 FMH-139 is a One Step HCG Urine Pregnancy Test iProven SEVENGROUND TRADING B.V.
24 08719699633230 FMH-139-5 FMH-139 is a One Step HCG Urine Pregnancy Test iProven SEVENGROUND TRADING B.V.
25 08719699630901 FMH-139-5 FMH-139 is a One Step HCG Urine Pregnancy Test iProven SEVENGROUND TRADING B.V.
26 08719481722043 FMH-139-5 Box with five midstream pregnancy tests iProvèn MASENA INVEST B.V.
27 08719481722029 FMH-139-3 Box with three midstream pregnancy tests iProvèn MASENA INVEST B.V.
28 08719481721077 FK-127s-A Fertility KIT with 30 teststrips iProvèn MASENA INVEST B.V.
29 08719481721046 FH-30-HCG-A Box with 30 pregnancy teststrips iProvèn MASENA INVEST B.V.
30 08719481720865 FK-127-A Fertility KIT with 70 teststrips iProvèn MASENA INVEST B.V.
31 08719481720759 FH-30 Box with 30 pregnancy teststrips iProvèn MASENA INVEST B.V.
32 08719481720728 FK-127s Box with 25 ovulation teststrips and 5 pregnancy teststrips iProvèn MASENA INVEST B.V.
33 08719481720179 FK-127-W-HCGtest HCG strips - pregnancy test strips - REGISTRATION NUMBER HCG STRIP: 21 CFR 862.1155 iProvèn MASENA INVEST B.V.
34 08719481720162 FK-127-HCGtest HCG strips - pregnancy test strips iProvèn MASENA INVEST B.V.
35 07350014630209 20 Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermomet Plan-a-pregnancy kit with Natural Cycles 6 month subscription, a basal thermometer, 10 ovulation strip tests and 5 pregnancy strip tests. Natural Cycles NATURALCYCLES NORDIC AB
36 07350014630155 15 Test, Pregnancy, Hcg, Over The Counter Natural Cycles NATURALCYCLES NORDIC AB
37 06974464590084 0741M4X003 One Step HCG Urine Test Midstream MissLan GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD
38 06974464590053 0741M4X002 LH and HCG combo test midstream MissLan GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD
39 06974464590046 0741M4X005 LH and HCG combo test midstream MissLan GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD
40 06974464590039 0731S3X020 LH and HCG combo test strip MissLan GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD
41 06970429840300 HCG Cassette Co-innovation CO-INNOVATION BIOTECH CO., LTD
42 06970429840164 1 HCG TEST PREGABLE CO-INNOVATION BIOTECH CO., LTD
43 06970429840157 HCG3.5 HCG TEST STRIP CO-INNOVATION BIOTECH CO., LTD
44 06970429840133 HCG Test Strip HealthyWiser CO-INNOVATION BIOTECH CO., LTD
45 06970429840126 HCG Pregnancy Test HCG Pregnancy Test Strip AICARE CO-INNOVATION BIOTECH CO., LTD
46 06970429840119 HCG TEST STRIP HCG TEST STRIP MomMed CO-INNOVATION BIOTECH CO., LTD
47 06970429840102 HCG Strip/4.0mm Co-innovation CO-INNOVATION BIOTECH CO., LTD
48 06970277512404 FHC-103H FHC-103H Pregnancy (hCG) Rapid Test Midstream Pregnancy (hCG) Rapid Test Midstream HANGZHOU ALLTEST BIOTECH CO., LTD.
49 06942820412332 HCG (2.0) One Step HCG Urine Pregnancy Test Strip ChoiceMMed BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
50 06938444985017 11C-1867-U RH-HCG-B LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitati LotFancy Pregnancy Test is a self-testing immunoassay designed for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 25pcs of 2.5mm strips in each box. LotFancy RUNBIO BIOTECH CO., LTD.