FDA UDI
In Commercial Distribution
🇺🇸 United States
simpli-COLLECT
DI: 00884999051690
·
Model: 09R16-001
·
ABBOTT MOLECULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- simpli-COLLECT
- Primary DI
- 00884999051690
- Version / Model
- 09R16-001
- Catalog Number
- 09R16-001
- Company Name
- ABBOTT MOLECULAR INC.
- Labeler DUNS
- 878263359
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-13
- Public Version
- 1
- Public Version Date
- 2026-04-21
- Public Version Status
- New
- Public Device Record Key
- 8eae2641-fcdd-4c59-824a-c2b46fb08345
Device Description
simpli-COLLECT HPV Collection Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LIO | Device, specimen collection | Microbiology | 866.2900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65666 | Urogenital specimen collection kit IVD, home-use | A collection of devices intended to be used by a layperson in the home and healthcare professionals for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20884999051694 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 00884999051690 | GS1 | ||||
| Package | 30884999051691 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1-800-553-7042
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius