FDA.report

Alpha-Tec Systems

Primary DI
00816085022673
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003316
Device description
ETM With CRC 36 sets
Published
2022-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JSJCulture Media, Selective And Non-Differential

Product Code Classifications

CodeDeviceSpecialtyClass
JSJCulture Media, Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816085022567PrimaryGS10
00816085022673Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085022567008160850225678160850225670816085022567
00816085022673008160850226738160850226730816085022673

GMDN Terms

TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
103105524
Device count
36
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00816085020075Alpha-Tec Systems0S0032222022-08-11
00816085020105Alpha-Tec Systems0S0032232022-08-11
00816085020273Alpha-Tec Systems02022-08-11
00816085020334Alpha-Tec Systems0S0032242022-08-11
00816085020167Alpha-Tec Systems000032482022-08-11
00816085020655Alpha-Tec Systems000033592022-08-11
00816085020877Alpha-Tec Systems0X0000202022-08-11
00816085020884Alpha-Tec Systems0X0034412022-08-11
00816085020891Alpha-Tec Systems0X0034572022-08-11
00816085020914Alpha-Tec Systems000043022022-08-11
00816085021010Alpha-Tec Systems02022-08-11
00816085021027Alpha-Tec Systems02022-08-11
00816085021034Alpha-Tec Systems02022-08-11
00816085021041Alpha-Tec Systems02022-08-11
00816085021058Alpha-Tec Systems02022-08-11
00816085021065Alpha-Tec Systems02022-08-11
00816085021157Alpha-Tec Systems000042082022-08-11
00816085021171Alpha-Tec Systems000042102022-08-11
00816085021188Alpha-Tec Systems000042132022-08-11
00816085021195Alpha-Tec Systems000042162022-08-11

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