Identity
- Trade Name
- PlaySafe™ FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted infections: (Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus I, Herpes simplex virus II, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum & Haemophilus ducreyi (chancroid). This device is intended for sample collection purpose only. Samples may be collected at home through adherence to the Instructions for Use (IFU) document or may be collected under the guidance of a medical professional. FDA UDI
- Model / Reference
- SCK10690 FDA UDI
- Description
- The PlaySafe kit is intended for use in the collection of a urine sample for laboratory analysis of nine sexually transmitted infections: (Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex virus I, Herpes simplex virus II, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum & Haemophilus ducreyi (chancroid). This device is intended for sample collection purpose only. Samples may be collected at home through adherence to the Instructions for Use (IFU) document or may be collected under the guidance of a medical professional. FDA UDI
Identifiers
- Catalog Number
- SCK10690 FDA UDI
- Primary DI / UDI-DI
- 05055273220018 FDA UDI
- FDA Product Code
- OIE FDA UDI
- GMDN Term
- Urine specimen collection kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urine specimen collection kit IVD
PlaySafe™ by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 2e2dd67e-85e9-4fff-b1a3-b991f725e377 36 fields · synced Jun 8, 2026