FDA.report

BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit

Primary DI
05055273221640
Brand
BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit
Company
RANDOX LABORATORIES LIMITED
Model
SCK10796
Catalog number
SCK10796
Device description
The Baseline Self-Draw (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.
Published
2026-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Product Code Classifications

CodeDeviceSpecialtyClass
PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)Clinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055273221640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055273221640050552732216405055273221640

GMDN Terms

TermDefinition
Capillary blood collection kit IVDA collection of in vitro diagnostic devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection container(s), and a return packing/envelope for mailing to the laboratory. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature00

Contacts

PhoneEmail
+1 310 310 3637customersupportusa@randox.com

Regulatory Flags

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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