# Shenyang Eksv Medical Equipment · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shenyang Eksv Medical Equipment · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips; product code is 75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) | 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) | 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) | 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 81 J - - IO Blood, Occult, Colorimetric, in Urine | 81 L - - JX Test, Urine Leukocyte | 83 J - - XA Kit, Screening, Urine; date published is 10/31/2011; address is 30 North Xinghua , Shenyang, CHINA, verified against its source on 2026-09-16.

- **Firm:** Shenyang Eksv Medical Equipment _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** 30 North Xinghua , Shenyang, CHINA _(verified: appears in the quote below)_
- **Date published:** 10/31/2011 _(verified: appears in the quote below)_
- **Product code:** 75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) | 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) | 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) | 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 81 J - - IO Blood, Occult, Colorimetric, in Urine | 81 L - - JX Test, Urine Leukocyte | 83 J - - XA Kit, Screening, Urine _(verified: each item appears in the quote below)_
- **Product:** EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips | EKSV-10A Urinalysis Test Strips _(verified: each item appears in the quote below)_
- **FDA notes:** class II | class II | Class II | class II | class II | class II | Class II | class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Shenyang Eksv Medical Equipment Date Published : 10/31/2011 30 North Xinghua , Shenyang, CHINA 75 C - - DM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 C - - EN Dye-Indicator, Ph (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - IL Enzymatic Method, Glucose (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 75 J - - IN Nitroprusside, Ketones (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - IR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - JB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 75 J - - MT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 81 J - - IO Blood, Occult, Colorimetric, in Urine Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: class II 81 L - - JX Test, Urine Leukocyte Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II 83 J - - XA Kit, Screening, Urine Date Published: 10/31/2011 Desc: EKSV-10A Urinalysis Test Strips Notes: Class II

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).