FDA UDI
In Commercial Distribution
🇺🇸 United States
500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)
DI: 00860013988036
·
Model: LLS200
·
ADVANCE DX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)
- Primary DI
- 00860013988036
- Version / Model
- LLS200
- Catalog Number
- LLS200
- Company Name
- ADVANCE DX, INC.
- Labeler DUNS
- 041235184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-03
- Public Version
- 1
- Public Version Date
- 2026-03-11
- Public Version Status
- New
- Public Device Record Key
- 7a4c84f7-df00-48b2-ae24-6061444eb0fe
Device Description
Advance Dx 500 Blood Collection Card (5-100 Packs) 500 Double strip cards and 500 foil-Lifeline
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63134 | Dried blood spot collection kit IVD | A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30860013988037 | GS1 | Pack | 500 | In Commercial Distribution | |
| Primary | 00860013988036 | GS1 |
Customer Contacts
- Phone
- 847-677-3825
- [email protected]